TABLETS (3 DOSES)3
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
MAXIMUM STRENGTH
150
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
Tips for managing heartburn • Eat slowly and do not eat big meals• f you are overweight, lose weight• f you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
®
Ranitidine Tablets 150 mg/Acid Reducer
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610, or visit www.zantacotc.com
Drug Facts (continued)
Distr
ibuted
by: C
hatte
m, In
c.,a S
anofi
Com
pany
P.O.
Box
221
9Ch
attan
ooga
, TN
3740
9-02
19©
2019
Or
igin M
exico
01
4004
8-01
Drug
Fac
tsAc
tive i
ngre
dien
t (in
each
tabl
et)
P
urpo
seRa
nitidi
ne 15
0 mg (
as ra
nitidi
ne hy
droc
hlorid
e 168
mg)
. . . .
. . . .
. . . .
. . . .
. . Ac
id re
duce
r
Uses
• reli
eves
hear
tburn
asso
ciated
with
acid
indige
stion
and s
our s
tomac
h• p
reve
nts h
eartb
urn a
ssoc
iated
with
acid
indige
stion
and s
our s
tomac
h bro
ught
on by
eati
ng or
drink
ing ce
rtain
foods
and b
ever
ages
War
nings
Aller
gy al
ert: D
o not
use i
f you
are a
lergic
to ra
nitidi
ne or
othe
r acid
redu
cers
Do no
t use
• if y
ou ha
ve tr
ouble
or pa
in sw
allow
ing fo
od, v
omitin
g with
bloo
d, or
bloo
dy or
blac
k
stools
. The
se m
ay be
sign
s of a
serio
us co
nditio
n. Se
e you
r doc
tor.
• with
othe
r acid
redu
cers
Ask a
docto
r befo
re us
e if y
ou ha
ve
•
had h
eartb
urn o
ver 3
mon
ths.
This
may
be a
sign o
f a m
ore s
eriou
s con
dition
.• h
eartb
urn w
ith lig
hthe
aded
ness
, swe
ating
or di
zzine
ss• c
hest
pain
or sh
oulde
r pain
with
shor
tnes
s of b
reath
; swe
ating
; pain
spre
ading
to
arm
s, ne
ck or
shou
lders;
or lig
hthe
aded
ness
• fre
quen
t che
st p
ain
• fr
eque
nt w
heez
ing, p
artic
ularly
with
hear
tbur
n• u
nexp
laine
d weig
ht lo
ss
• na
usea
or vo
mitin
g •
stom
ach p
ain
• kid
ney d
iseas
e As
k a do
ctor
or ph
arm
acist
befo
re us
e if y
ou ar
e tak
ing a
pres
cript
ion dr
ug. A
cid
redu
cers
may
inter
act w
ith ce
rtain
pres
cript
ion dr
ugs.
Stop
use
and
ask
a d
octo
r if
•
your
hea
rtbur
n co
ntinu
es o
r wor
sens
• you
nee
d to
take
this
prod
uct f
or m
ore
than
14
days
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
hea
lth p
rofe
ssion
al be
fore
use
. Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get
med
ical h
elp o
r con
tact
a
Poiso
n Co
ntro
l Cen
ter r
ight a
way.
Dire
ction
s•
adult
s and
child
ren
12 ye
ars a
nd o
ver:
•
to re
lieve
sym
ptom
s, sw
allow
1 ta
blet w
ith a
glas
s of w
ater
• t
o pr
even
t sym
ptom
s, sw
allow
1 ta
blet w
ith a
glas
s of w
ater
30
to 6
0 m
inut
es
befo
re ea
ting
food
or d
rinkin
g be
vera
ges t
hat c
ause
hea
rtbur
n
• ca
n be
use
d up
to tw
ice d
aily (
do n
ot ta
ke m
ore
than
2 ta
blets
in 24
hou
rs)
• ch
ildre
n un
der 1
2 ye
ars:
ask
a do
ctor
Othe
r inf
orm
ation
• sto
re at
20-2
5ºC
(68-
77ºF
)
• do n
ot us
e if in
dividu
al bli
ster u
nit is
open
or to
rn
•
avoid
exce
ssive
heat
or hu
midi
ty
• th
is pr
oduc
t is so
dium
and s
ugar
free
Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.
Zantac 150 3ct Carton
ZAN_150_3ct_CTN_0140048-01_Mex_2019_FDA_DSN306.13.19
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 06/13/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
5.8 pt.
0 to 8 pt.
8 point type
9.0 point type
9.0 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) La gest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 60mm W 97mm0.070 in
V 8.81 pt. H 0.00 pt
V 15% H 0%
V 61 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
TABLETS (3 DOSES)3
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
MAXIMUM STRENGTH
150
®
Ranitidine Tablets 150 mg/Acid Reducer
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
Tips for managing heartburn • Eat slowly and do not eat big meals• f you are overweight, lose weight• f you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn.
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610, or visit www.zantacotc.com
Drug Facts (continued)
Drug
Fac
tsAc
tive i
ngre
dien
t (in
each
tabl
et)
P
urpo
seRa
nitidi
ne 15
0 mg (
as ra
nitidi
ne hy
droc
hlorid
e 168
mg)
. . . .
. . . .
. . . .
. . . .
. . Ac
id re
duce
r
Uses
• reli
eves
hear
tburn
asso
ciated
with
acid
indige
stion
and s
our s
tomac
h• p
reve
nts h
eartb
urn a
ssoc
iated
with
acid
indige
stion
and s
our s
tomac
h bro
ught
on by
eati
ng or
drink
ing ce
rtain
foods
and b
ever
ages
War
nings
Aller
gy al
ert: D
o not
use i
f you
are a
lergic
to ra
nitidi
ne or
othe
r acid
redu
cers
Do no
t use
• if y
ou ha
ve tr
ouble
or pa
in sw
allow
ing fo
od, v
omitin
g with
bloo
d, or
bloo
dy or
blac
k
stools
. The
se m
ay be
sign
s of a
serio
us co
nditio
n. Se
e you
r doc
tor.
• with
othe
r acid
redu
cers
Ask a
docto
r befo
re us
e if y
ou ha
ve
•
had h
eartb
urn o
ver 3
mon
ths.
This
may
be a
sign o
f a m
ore s
eriou
s con
dition
.• h
eartb
urn w
ith lig
hthe
aded
ness
, swe
ating
or di
zzine
ss• c
hest
pain
or sh
oulde
r pain
with
shor
tnes
s of b
reath
; swe
ating
; pain
spre
ading
to
arm
s, ne
ck or
shou
lders;
or lig
hthe
aded
ness
• fre
quen
t che
st p
ain
• fr
eque
nt w
heez
ing, p
artic
ularly
with
hear
tbur
n• u
nexp
laine
d weig
ht lo
ss
• na
usea
or vo
mitin
g •
stom
ach p
ain
• kid
ney d
iseas
e As
k a do
ctor
or ph
arm
acist
befo
re us
e if y
ou ar
e tak
ing a
pres
cript
ion dr
ug. A
cid
redu
cers
may
inter
act w
ith ce
rtain
pres
cript
ion dr
ugs.
Stop
use
and
ask
a d
octo
r if
•
your
hea
rtbur
n co
ntinu
es o
r wor
sens
• you
nee
d to
take
this
prod
uct f
or m
ore
than
14
days
If pr
egna
nt o
r bre
ast-f
eedi
ng, a
sk a
hea
lth p
rofe
ssion
al be
fore
use
. Ke
ep o
ut o
f rea
ch o
f chi
ldre
n. In
case
of o
verd
ose,
get
med
ical h
elp o
r con
tact
a
Poiso
n Co
ntro
l Cen
ter r
ight a
way.
Dire
ction
s•
adult
s and
child
ren
12 ye
ars a
nd o
ver:
•
to re
lieve
sym
ptom
s, sw
allow
1 ta
blet w
ith a
glas
s of w
ater
• t
o pr
even
t sym
ptom
s, sw
allow
1 ta
blet w
ith a
glas
s of w
ater
30
to 6
0 m
inut
es
befo
re ea
ting
food
or d
rinkin
g be
vera
ges t
hat c
ause
hea
rtbur
n
• ca
n be
use
d up
to tw
ice d
aily (
do n
ot ta
ke m
ore
than
2 ta
blets
in 24
hou
rs)
• ch
ildre
n un
der 1
2 ye
ars:
ask
a do
ctor
Othe
r inf
orm
ation
• sto
re at
20-2
5ºC
(68-
77ºF
)
• do n
ot us
e if in
dividu
al bli
ster u
nit is
open
or to
rn
•
avoid
exce
ssive
heat
or hu
midi
ty
• th
is pr
oduc
t is so
dium
and s
ugar
free
Distr
ibuted
by: C
hatte
m, In
c.,a S
anofi
Com
pany
P.O.
Box
221
9Ch
attan
ooga
, TN
3740
9-02
19©
2019
Or
igin S
pain
0140
047-
01
Zantac 150 3ct Carton
ZAN_150_3ct_CTN_0140047-01_Spain_2019_FDA_DSN306.13.19
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 06/13/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
5.8 pt.
0 to 8 pt.
8 point type
9.0 point type
9.0 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) La gest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 60mm W 97mm0.070 in
V 8.81 pt. H 0.00 pt
V 15% H 0%
V 61 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
MAXIMUM STRENGTH
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (8 DOSES)8
MAXIMUM STRENGTH
150
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
®
ZANT
AC d
oes n
ot su
pply
stor
e br
ands
LOT
EXP
Read
the
dire
ctio
ns a
nd w
arni
ngs
befo
re u
se.
Keep
the
cart
on. I
t con
tain
s im
port
ant i
nfor
mat
ion
incl
udin
g tip
s fo
r man
agin
g he
artb
urn.
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Tips for managing heartburn
Distributed by: Chattem, Inc., a Sanofi CompanyP.O. Box 2219Chattanooga, TN 37409-0219©2019 Origin Mexico 0140046-01
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if individual blister unit is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
Zantac 150 8ct Carton
ZAN_150_8ct_CTN_0140046-01_Mex_2019_FDA_DSN203.28.19
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/28/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
MAXIMUM STRENGTH
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (8 DOSES)8
MAXIMUM STRENGTH
150
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
®
ZANT
AC d
oes n
ot su
pply
stor
e br
ands
LOT
EXP
Read
the
dire
ctio
ns a
nd w
arni
ngs
befo
re u
se.
Keep
the
cart
on. I
t con
tain
s im
port
ant i
nfor
mat
ion
incl
udin
g tip
s fo
r man
agin
g he
artb
urn.
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Tips for managing heartburn
Distributed by: Chattem, Inc., a Sanofi CompanyP.O. Box 2219Chattanooga, TN 37409-0219©2019 Origin Spain 0140045-01
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if individual blister unit is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
Zantac 150 8ct Carton
ZAN_150_8ct_CTN_0140045-01_Spain_2019_FDA_DSN303.28.19
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/28/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
ZANT
AC d
oes n
ot su
pply
stor
e br
ands
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if individual blister unit is open or torn• store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140044-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Tips for managing heartburn
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
MAXIMUM STRENGTH
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (24 DOSES)24
MAXIMUM STRENGTH
150
MA
XIM
UM
STR
ENG
TH
150
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
®
MA
XIM
UM
STRENG
TH
150Ranitidine Tablets 150 m
g / Acid Reducer
Zantac 150 24ct Carton03.18.19
ZAN_150_24ct_CTN_0140044-01_Mex_2019_FDA_DSN2
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/18/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
5.9 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
ZANT
AC d
oes n
ot su
pply
stor
e br
ands
MORE TIPS ON BOTTOM PANEL
MAXIMUM STRENGTH
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (24 DOSES)24
MAXIMUM STRENGTH
150
MA
XIM
UM
STR
ENG
TH
150
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
®
MA
XIM
UM
STRENG
TH
150Ranitidine Tablets 150 m
g / Acid Reducer
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if individual blister unit is open or torn• store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Spain
0140043-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Tips for managing heartburn
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Zantac 150 24ct Carton03.14.19
ZAN_150_24ct_CTN_0140043-01_Spain_2019_FDA_DSN
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
5.9 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
ZANT
AC d
oes n
ot su
pply
stor
e br
ands
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (32 DOSES)24
MAXIMUM STRENGTH
150
MA
XIM
UM
STRENG
TH
150 MA
XIM
UM
STR
ENG
TH
150
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
®
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if individual blister unit is open or torn• store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140074-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Tips for managing heartburn
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
BONUS! 8 FREE TABLETSBONUS! 8 FREE TABLETS
32
Zantac 150 32ct Carton03.14.19
ZAN_150_32ct_Bonus_CTN_0140074-01_Mex_2019_FDA_DSN
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
5.9 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
ZANT
AC d
oes n
ot su
pply
stor
e br
ands
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (32 DOSES)24
MAXIMUM STRENGTH
150
MA
XIM
UM
STRENG
TH
150 MA
XIM
UM
STR
ENG
TH
150
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
®
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if individual blister unit is open or torn• store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Spain
0140077-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Tips for managing heartburn
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
BONUS! 8 FREE TABLETSBONUS! 8 FREE TABLETS
32
Zantac 150 32ct Carton03.06.19
ZAN_150_32ct_Bonus_CTN_0140077-01_Spain_2019_FDA_DSN2
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/06/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
5.9 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
TABL
ETS
(40
DO
SES)
40
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
TABLETS
(40 DO
SES)40
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (40 DOSES)40®
Ranitidine Tablets 150 mg / Acid Reducer
ZANTAC does not supply store brands
150150
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140071-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_40ct_CTN_ 0140071-01_Mex_2019_FDA_DSN03.14.19
Zantac 150 40ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
TABL
ETS
(40
DO
SES)
40
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
TABLETS
(40 DO
SES)40
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (40 DOSES)40®
Ranitidine Tablets 150 mg / Acid Reducer
ZANTAC does not supply store brands
150150
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Spain
0140070-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_40ct_CTN_0140070-01_Spain_2019_FDA_DSN03.14.19
Zantac 150 40ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
TABL
ETS
(50
DO
SES)
50
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
TABLETS
(50 DO
SES)50
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (50 DOSES)50®
Ranitidine Tablets 150 mg / Acid Reducer
ZANTAC does not supply store brands
150150
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140042-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_50ct_CTN_0140042-01_Mex_2019_FDA_DSN03.14.19
Zantac 150 50ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
TABL
ETS
(50
DO
SES)
50
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
TABLETS
(50 DO
SES)50
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (50 DOSES)50®
Ranitidine Tablets 150 mg / Acid Reducer
ZANTAC does not supply store brands
150150
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Spain
0140041-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_50ct_CTN_0140041-01_Spain_2019_FDA_DSN03.14.19
Zantac 150 50ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
TABL
ETS
(65
DO
SES)
65
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
TABLETS
(65 DO
SES)65
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (65 DOSES)65®
Ranitidine Tablets 150 mg / Acid Reducer
ZANTAC does not supply store brands
150150
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140039-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_65ct_CTN_0140039-01_Mex_2019_FDA_DSN02.28.19
Zantac 150 65ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 02/28/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
TABL
ETS
(65
DO
SES)
65
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
TABLETS
(65 DO
SES)65
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (65 DOSES)65®
Ranitidine Tablets 150 mg / Acid Reducer
ZANTAC does not supply store brands
150150
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Spain
0140040-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_65ct_CTN_0140040-01_Spain_2019_FDA_DSN03.14.19
Zantac 150 65ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
MAXIMUM STRENGTH
MAXIMUM STRENGTH
BONUS! 13 FREE TABLETSBONUS! 13 FREE TABLETS
TABLETS
(78 DO
SES)78
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (78 DOSES)6578®
ZANTAC does not supply store brands
TABL
ETS
(78
DO
SES)
78
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Ta
blet
s 15
0 m
g / A
cid
Redu
cer
Ranitidine Tablets 150 mg / Acid Reducer150
150Ranitidine Tablets 150 mg / Acid Reducer
150150
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140036-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_78ct_Bonus_CTN_0140036-01_Mex_2019_FDA_DSN02.28.19
Zantac 150 78ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 02/28/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
MAXIMUM STRENGTH
MAXIMUM STRENGTH
BONUS! 13 FREE TABLETSBONUS! 13 FREE TABLETS
TABLETS
(78 DO
SES)78
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (78 DOSES)6578®
ZANTAC does not supply store brands
TABL
ETS
(78
DO
SES)
78
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Ta
blet
s 15
0 m
g / A
cid
Redu
cer
Ranitidine Tablets 150 mg / Acid Reducer150
150Ranitidine Tablets 150 mg / Acid Reducer
150150
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Spain
0140072-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_78ct_Bonus_CTN_0140072-01_Spain_2019_FDA_DSN03.14.19
Zantac 150 78ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney diseaseAsk a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours)• children under 12 years: ask a doctor
Other information• do not use if individual foil pouch is open or torn • store at 20-25ºC (68-77ºF) • avoid excessive heat or humidity • this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140081-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Tips for managing heartburn
MAXIMUM STRENGTH
150
TABLET (1 DOSE) 1POUCHES 80
TO OPENPUSH IN TAB AND PULL OUT
MAXIMUM STRENGTH
150
MAXIMUM STRENGTH
150
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
Ranitidine Tablets 150 mg / Acid Reducer
Do not discard this carton.It contains important consumer information.
®
®
®
®
Zantac 150 1ct Sachet/Pouch Dispenser (80ct)03.18.19
ZAN_150_80ct_Dispenser_0140081-01_Mex_2019_FDA_DSN
Zantac 150 1ct Sachet/Pouch Dispenser (80ct)
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/18/19
YES
6 point type
7 point type
7 point type
.5 pt.
30
97%-102%
2.5 pt.
6.5 pt.
0 to 8 pt.
9.25 point type
10 point type
11.5 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in inches)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 4.00 in W 4.75 in.0903 in
V 13 pt. H 0.00 pt.
V 15% H 0%
V 94 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney diseaseAsk a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours)• children under 12 years: ask a doctor
Other information• do not use if individual foil pouch is open or torn• store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Spain
0140080-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Tips for managing heartburn
MAXIMUM STRENGTH
150
TABLET (1 DOSE) 1POUCHES 80
TO OPENPUSH IN TAB AND PULL OUT
MAXIMUM STRENGTH
150
MAXIMUM STRENGTH
150
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
150
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
Ranitidine Tablets 150 mg / Acid Reducer
Do not discard this carton.It contains important consumer information.
®
®
®
®
Zantac 150 1ct Sachet/Pouch Dispenser (80ct)03.12.19
ZAN_150_80ct_Dispenser_0140080-01_Spain_2019_FDA_DSN3
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/12/19
YES
6 point type
7 point type
7 point type
.5 pt.
30
97%-102%
2.5 pt.
6.5 pt.
0 to 8 pt.
9.25 point type
10 point type
11.5 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in inches)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 4.00 in W 4.75 in.0903 in
V 13 pt. H 0.00 pt.
V 15% H 0%
V 94 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140038-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTHVALUE SIZE 90 TABLETSVALUE SIZE 90 TABLETS
TABLETS
(90 DO
SES)90
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (90 DOSES)90®
ZANTAC does not supply store brands
TABL
ETS
(90
DO
SES)
90
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Ta
blet
s 15
0 m
g / A
cid
Redu
cer
Ranitidine Tablets 150 mg / Acid Reducer150
150150
ZAN_150_90ct_Bonus_CTN_0140038-01_Mex_2019_FDA_DSN03.14.19
Zantac 150 90ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
ZAN_150_90ct_Bonus_CTN_0140037-01_Spain_2019_FDA_DSN03.14.19
Zantac 150 90ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
MAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTHVALUE SIZE 90 TABLETSVALUE SIZE 90 TABLETS
TABLETS
(90 DO
SES)90
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS (90 DOSES)90®
ZANTAC does not supply store brands
TABL
ETS
(90
DO
SES)
90
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Ta
blet
s 15
0 m
g / A
cid
Redu
cer
Ranitidine Tablets 150 mg / Acid Reducer150
150150
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Spain
0140037-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
Reference ID: 4493200
MAXIMUM STRENGTH
150
®
Twin Pack 2 Bottles x 70ct = 140ct
PREVENTS &RELIEVESHEARTBURNassociated withacid indigestionand sour stomach
TABLETS (140 DOSES)
140
Ranitidine Tablets 150 mg / Acid ReducerMAXIMUM STRENGTH
150Ranitidine Tablets 150 mg / Acid Reducer
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney diseaseAsk a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours)• children under 12 years: ask a doctor
Other information• do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF)• avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019
0140082-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Tips for managing heartburn
Read the directions and warnings before use. Keep the card. It contains important information including tips for managing heartburn.
KO VarnishLot Code
Zantac 150 Twin Card (140ct)03.25.19
ZAN_150_TWIN_140CT_Card_0140082-01_2019_FDA_DSN5
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/25/19
YES
6 point type
7 point type
7 point type
.5 pt.
39
97%-102%
2.5 pt.
6.5 pt.
0 to 8 pt.
9.25 point type
10 point type
11.5 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in inches)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 6.75 in W 7.75 in.0903 in
V 13 pt. H 0.00 pt.
V 15% H 0%
V 94 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
LOT
EXP
Read
the
dire
ctio
ns a
nd w
arni
ngs
befo
re u
se.
Keep
the
cart
on. I
t con
tain
s im
port
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ZANT
AC d
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ands
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
Releases a
Throatin Mouth &
Cooling Sensation
TABLETS(8 DOSES)8SUGAR FREE
COOL MINT TABLETS
MAXIMUM STRENGTH
Ranitidine Tablets 150 mg/Acid Reducer
™
150Ranitid ne Tablets 150 mg / Acid Reducer
COOL MINT TABLETS
MAXIMUM STRENGTH
MORE TIPS ON BOTTOM PANEL
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • do not chew tablet • children under 12 years: ask a doctor
Other information • do not use if individual blister unit is open or torn • store at 20-25ºC (68-77ºF) • avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients FD&C Blue No.1, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Tips for managing heartburn
Distributed by: Chattem, Inc., a Sanofi CompanyP.O. Box 2219Chattanooga, TN 37409-0219©2019 Origin Mexico 0140069-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
Tips for managing heartburn
Zantac 150 Cool Mint 8ct Carton
ZAN_150_CoolMint_8ct_CTN_0140069-01_Mex_2019_FDA_DSN303.28.19
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/28/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
ZANT
AC d
oes n
ot su
pply
stor
e br
ands
150
150
50
Rani
tidin
e Tab
lets
50 m
g / A
cid
Redu
cer
CO
OL
MIN
T TA
BLE
TS
MA
XIM
UM
STR
ENG
TH
CO
OL M
INT TA
BLETS
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTHCOOL MINT TABLETS
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
Releases a
Throatin Mouth &
Cooling Sensation
TABLETS(24 DOSES)24SUGAR FREE
COOL MINT TABLETS
MAXIMUM STRENGTH
Ranitidine Tablets 150 mg/Acid Reducer
™
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140068-01
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • do not chew tablet • children under 12 years: ask a doctor
Other information • do not use if individual blister unit is open or torn • store at 20-25ºC (68-77ºF) • avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients FD&C Blue No.1, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
Zantac 150 Cool Mint 24ct Carton03.14.19
ZAN_150_CoolMint_24ct_CTN_0140068-01_Mex_2019_FDA_DSN
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
5.9 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
ZANT
AC d
oes n
ot su
pply
stor
e br
ands
50
150
150
Rani
tidin
e Tab
lets
150 m
g / A
cid
Redu
cer
CO
OL
MIN
T TA
BLE
TS
MA
XIM
UM
STR
ENG
TH
CO
OL M
INT TA
BLETS
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTH
COOL MINT TABLETS
150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
Releases a
Throatin Mouth &
Cooling Sensation
TABLETS(32 DOSES)24SUGAR
FREE
COOL MINT TABLETS
MAXIMUM STRENGTH
Ranitidine Tablets 150 mg/Acid Reducer
™
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140075-01
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • do not chew tablet • children under 12 years: ask a doctor
Other information • do not use if individual blister unit is open or torn • store at 20-25ºC (68-77ºF) • avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients FD&C Blue No.1, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
BONUS! 8 FREE TABLETSBONUS! 8 FREE TABLETS
32
Zantac 150 Cool Mint 32ct Carton03.06.19
ZAN_150_CoolMint_32ct_Bonus_CTN_0140075-01_Mex_2019_FDA_DSN2
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/06/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
5.9 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
150Ranitidine Tablets 150 mg/Acid Reducer
COOL MINT TABLETS
MAXIMUM STRENGTH
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS(40 DOSES)40SUGAR FREE
ZANTAC does not supply store brands
150Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTHCOOL MINT TABLETS
150150
CO
OL
MIN
T TA
BLE
TS
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
TABL
ETS
(40
DO
SES)
40
CO
OL M
INT TA
BLETS
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
TABLETS
(40 DO
SES)40
Releases a
Throatin Mouth &
Cooling Sensation
™
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140063-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • do not chew tablet • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF) • avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients FD&C Blue No.1, flavors, hypromellose, magnesium stearate, microcrystaline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_Coolmint_40ct_CTN_0140063-01_MEX_2019_FDA_DSN.ai02.28.19
Zantac 150 Coolmint 40ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 02/28/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
150Ranitidine Tablets 150 mg/Acid Reducer
COOL MINT TABLETS
MAXIMUM STRENGTH
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS(50 DOSES)50SUGAR FREE
ZANTAC does not supply store brands
150Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTHCOOL MINT TABLETS
150150
CO
OL
MIN
T TA
BLE
TS
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
TABL
ETS
(50
DO
SES)
50
CO
OL M
INT TA
BLETS
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
TABLETS
(50 DO
SES)50
Releases a
Throatin Mouth &
Cooling Sensation
™
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140067-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • do not chew tablet • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF) • avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients FD&C Blue No.1, flavors, hypromellose, magnesium stearate, microcrystaline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_CoolMint_50ct_CTN_0140067-01_Mex_2019_FDA_DSN03.14.19
Zantac 150 Coolmint 50ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
150Ranitidine Tablets 150 mg/Acid Reducer
COOL MINT TABLETS
MAXIMUM STRENGTH
PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS(65 DOSES)65SUGAR FREE
ZANTAC does not supply store brands
150Ranitidine Tablets 150 mg / Acid Reducer
MAXIMUM STRENGTHCOOL MINT TABLETS
150150
CO
OL
MIN
T TA
BLE
TS
MA
XIM
UM
STR
ENG
TH
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
r
TABL
ETS
(65
DO
SES)
65
CO
OL M
INT TA
BLETS
MA
XIM
UM
STRENG
TH
Ranitidine Tablets 150 mg / Acid Reducer
TABLETS
(65 DO
SES)65
Releases a
Throatin Mouth &
Cooling Sensation
™
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140066-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • do not chew tablet • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF) • avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients FD&C Blue No.1, flavors, hypromellose, magnesium stearate, microcrystaline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_Coolmint_65ct_CTN_0140066-01_Mex_2019_FDA_DSN03.14.19
Zantac 150 Coolmint 65ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
150
COOL MINT TABLETS
MAXIMUM STRENGTH
Ranitidine Tablets 150 mg/Acid Reducer
TABL
ETS
(78
DO
SES)
78MA
XIM
UM
STR
ENG
TH
TABLETS
(78 DO
SES)78
Releases a
Throatin Mouth &
Cooling Sensation PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
TABLETS(78 DOSES)65SUGAR
FREE 78
COOL MINT TABLETS
MAXIMUM STRENGTH
MA
XIM
UM
STRENG
TH
BONUS! 13 FREE TABLETSBONUS! 13 FREE TABLETS
™
ZANTAC does not supply store brandsCO
OL
MIN
T TA
BLE
TSCO
OL M
INT TA
BLETS Ra
nitid
ine T
able
ts 15
0 m
g / A
cid
Redu
cer
Ranitidine Tablets 150 mg / Acid Reducer
150Ranitidine Tablets 150 mg/Acid Reducer
150150
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140065-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • do not chew tablet • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF) • avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients FD&C Blue No.1, flavors, hypromellose, magnesium stearate, microcrystaline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_Coolmint_78ct_Bonus_CTN_0140065-01_Mex_2019_FDA_DSN03.14.19
Zantac 150 Coolmint 78ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
150
COOL MINT TABLETS
MAXIMUM STRENGTH
Ranitidine Tablets 150 mg/Acid Reducer
MA
XIM
UM
STR
ENG
TH
TABLETS(90 DOSES)90SUGAR
FREE
Rani
tidin
e Tab
lets
150
mg /
Aci
d Re
duce
rRanitidine Tablets 150 m
g / Acid Reducer
MA
XIM
UM
STRENG
TH
TABL
ETS
(90
DO
SES)
90TA
BLETS (90 D
OSES)
90
ZANTAC does not supply store brands
Releases a
Throatin Mouth &
Cooling Sensation PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach
150
COOL MINT TABLETS
MAXIMUM STRENGTH
VALUE SIZE 90 TABLETSVALUE SIZE 90 TABLETS
™
Ranitidine Tablets 150 mg/Acid Reducer
CO
OL
MIN
T TA
BLE
TSCO
OL M
INT TA
BLETS
150150
Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico
0140064-01
• Do not lie flat or bend over soon after eating• Do not eat late at night, or just before bedtime• Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
MORE TIPS ON BOTTOM PANEL
Tips for managing heartburn
• Eat slowly and do not eat big meals• If you are overweight, lose weight• If you smoke, quit smoking• Raise the head of your bed• Wear loose fitting clothing around your stomach
Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.
Tips for managing heartburn
Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn • can be used up to twice daily (do not take more than 2 tablets in 24 hours) • do not chew tablet • children under 12 years: ask a doctor
Other information • do not use if printed foil under bottle cap is open or torn • store at 20-25ºC (68-77ºF) • avoid excessive heat or humidity• this product is sodium and sugar free
Inactive ingredients FD&C Blue No.1, flavors, hypromellose, magnesium stearate, microcrystaline cellulose, polyethylene glycol, polysorbate 80, sucralose, titanium dioxide
Questions? call 1-800-633-1610 or visit www.zantacotc.com
Drug FactsActive ingredient (in each tablet) PurposeRanitidine 150 mg(as ranitidine hydrochloride 168 mg) . . . . . . . . . . . Acid reducer
Uses• relieves heartburn associated with acid indigestion and sour stomach• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
WarningsAllergy alert: Do not use if you are allergic to ranitidine or other acid reducersDo not use • if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.• with other acid reducersAsk a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition.• heartburn with lightheadedness, sweating or dizziness• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness• frequent chest pain• frequent wheezing, particularly with heartburn• unexplained weight loss • nausea or vomiting• stomach pain • kidney disease
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.Stop use and ask a doctor if • your heartburn continues or worsens• you need to take this product for more than 14 days
ZAN_150_Coolmint_90ct_Value_CTN_0140064-01_Mex_2019_FDA_DSN03.14.19
Zantac 150 Coolmint 90ct Carton
Sanofi Regulatory SpecificationsDrug Facts Info
Principal Display Panel Info
Verified Date: 03/14/19
YES
5 point type
6 point type
6 point type
0.5 pt.
39
97%-102%
2.5 pt.
6.0 pt.
0 to 8 pt.
8 point type
9 point type
10 point type
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 57 Condensed
Font name: Helvetica Neue 77 Bold Condensed
Hairlines:
Maximum Characters/Inch:
Horizontal Scale:
Barlines:
Leading (Minimum space in body of Drug Facts):
PDP dimensions (in millimeters)Font size of Net Quantity of Contents (Smallest character height in inches)
Font size of Statement of Identity (If not live text, to be measured in Helvetica capital “M”)
Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP
Font size of Logo/Largest Copy on PDP (If not live text, to be measured in Helvetica capital “M”)
H 89mm W 97mm0.088 in
V 11.5 pt. H 0.00 pt.
V 15% H 0%
V 82 pt. H 0.00 pt.
Tracking:
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Font name: Helvetica Neue 77 Bold Condensed Oblique
Bullets
Body Text
Subheadings
Headings
Drug Facts (continued)
Drug Facts (Title)
YES
Bullets on same lines: end of statement separated from bulleted statement by two ems
Spacing of the hairlines from edge of box – i.e. Minimum of 1 space either side of Drug Facts Box
Reference ID: 4493200
--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically. Following this are manifestations of any and allelectronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------
VALERIE S PRATT09/18/2019 02:41:47 PM
Signature Page 1 of 1
Reference ID: 4493200
(