Zantac 150 3ct Carton 06.13 › drugsatfda_docs › label › 2019 › 02… · MORE TIPS ON BOTTOM...

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 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



Bullets

Body Text

Subheadings

Headings


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


MAXIMUM STRENGTH

150

®



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.


Questions? call 1-800-633-1610, or visit www.zantacotc.com


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


ZAN_150_3ct_CTN_0140047-01_Spain_2019_FDA_DSN306.13.19




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




Hairlines:


Horizontal Scale:

Barlines:




Statement of Identity (pt.) (Divided by) La gest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP


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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




MAXIMUM STRENGTH

150PREVENTS & RELIEVESHEARTBURN associated with acid indigestion and sour stomach

TABLETS (8 DOSES)8

MAXIMUM STRENGTH

150

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.


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


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


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






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




Hairlines:


Horizontal Scale:

Barlines:




Statement of Identity (pt.) (Divided by) Largest Logo Copy (pt.)Ratio of Statement of Identity to Logo/Largest Copy on PDP


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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




MAXIMUM STRENGTH


TABLETS (8 DOSES)8

MAXIMUM STRENGTH

150



®

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.






Distributed by: Chattem, Inc., a Sanofi CompanyP.O. Box 2219Chattanooga, TN 37409-0219©2019 Origin Spain 0140045-01



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












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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




ZANT

AC d

oes n

ot su

pply

stor

e br

ands



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







Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Mexico

0140044-01






Read the directions and warnings before use. Keep the carton.It contains important information including tips for managing heartburn.

MAXIMUM STRENGTH


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



®

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




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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




ZANT

AC d

oes n

ot su

pply

stor

e br

ands


MAXIMUM STRENGTH



MAXIMUM STRENGTH

150

MA

XIM

UM

STR

ENG

TH

150

Rani

tidin

e Tab

lets

150

mg /

Aci

d Re

duce

r



®

MA

XIM

UM

STRENG

TH

150Ranitidine Tablets 150 m

g / Acid Reducer










Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019 Origin Spain

0140043-01








ZAN_150_24ct_CTN_0140043-01_Spain_2019_FDA_DSN




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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




ZANT

AC d

oes n

ot su

pply

stor

e br

ands



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



®











0140074-01







BONUS! 8 FREE TABLETSBONUS! 8 FREE TABLETS

32


ZAN_150_32ct_Bonus_CTN_0140074-01_Mex_2019_FDA_DSN




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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




ZANT

AC d

oes n

ot su

pply

stor

e br

ands



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




®











0140077-01








32


ZAN_150_32ct_Bonus_CTN_0140077-01_Spain_2019_FDA_DSN2




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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




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


MAXIMUM STRENGTH


MAXIMUM STRENGTH


TABLETS (40 DOSES)40®


ZANTAC does not supply store brands

150150


0140071-01









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







ZAN_150_40ct_CTN_ 0140071-01_Mex_2019_FDA_DSN03.14.19





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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




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


MAXIMUM STRENGTH


MAXIMUM STRENGTH





150150


0140070-01





















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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




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


MAXIMUM STRENGTH


MAXIMUM STRENGTH





150150


0140042-01





















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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




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


MAXIMUM STRENGTH


MAXIMUM STRENGTH





150150


0140041-01





















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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




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


MAXIMUM STRENGTH


MAXIMUM STRENGTH





150150


0140039-01





















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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




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


MAXIMUM STRENGTH


MAXIMUM STRENGTH





150150


0140040-01





















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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




MAXIMUM STRENGTH

MAXIMUM STRENGTH


TABLETS

(78 DO

SES)78

MA

XIM

UM

STRENG

TH





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


150150


0140036-01
















ZAN_150_78ct_Bonus_CTN_0140036-01_Mex_2019_FDA_DSN02.28.19





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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




MAXIMUM STRENGTH

MAXIMUM STRENGTH


TABLETS

(78 DO

SES)78

MA

XIM

UM

STRENG

TH





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



150150


0140072-01
















ZAN_150_78ct_Bonus_CTN_0140072-01_Spain_2019_FDA_DSN03.14.19





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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES






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


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




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


MAXIMUM STRENGTH

150

TABLET (1 DOSE) 1POUCHES 80

TO OPENPUSH IN TAB AND PULL OUT

MAXIMUM STRENGTH

150

MAXIMUM STRENGTH

150



MAXIMUM STRENGTH





MAXIMUM STRENGTH

150



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)




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




Hairlines:


Horizontal Scale:

Barlines:


PDP dimensions (in inches)Font size of Net Quantity of Contents (Smallest character height in inches)




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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES









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




0140080-01



MAXIMUM STRENGTH

150

TABLET (1 DOSE) 1POUCHES 80

TO OPENPUSH IN TAB AND PULL OUT

MAXIMUM STRENGTH

150

MAXIMUM STRENGTH

150



MAXIMUM STRENGTH





MAXIMUM STRENGTH

150



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




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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES





0140038-01
















MAXIMUM STRENGTH


MAXIMUM STRENGTHVALUE SIZE 90 TABLETSVALUE SIZE 90 TABLETS

TABLETS

(90 DO

SES)90

MA

XIM

UM

STRENG

TH





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


150150

ZAN_150_90ct_Bonus_CTN_0140038-01_Mex_2019_FDA_DSN03.14.19





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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




ZAN_150_90ct_Bonus_CTN_0140037-01_Spain_2019_FDA_DSN03.14.19





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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES



MAXIMUM STRENGTH


MAXIMUM STRENGTHVALUE SIZE 90 TABLETSVALUE SIZE 90 TABLETS

TABLETS

(90 DO

SES)90

MA

XIM

UM

STRENG

TH





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


150150


0140037-01

















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







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



Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219Chattanooga, TN 37409-0219 ©2019

0140082-01



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




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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




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.

ZANT

AC d

oes n

ot su

pply

stor

e br

ands


Releases a

Throatin Mouth &

Cooling Sensation

TABLETS(8 DOSES)8SUGAR FREE

COOL MINT TABLETS

MAXIMUM STRENGTH


™

150Ranitid ne Tablets 150 mg / Acid Reducer

COOL MINT TABLETS

MAXIMUM STRENGTH



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








Distributed by: Chattem, Inc., a Sanofi CompanyP.O. Box 2219Chattanooga, TN 37409-0219©2019 Origin Mexico 0140069-01



Zantac 150 Cool Mint 8ct Carton

ZAN_150_CoolMint_8ct_CTN_0140069-01_Mex_2019_FDA_DSN303.28.19




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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




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



MAXIMUM STRENGTHCOOL MINT TABLETS


Releases a

Throatin Mouth &

Cooling Sensation


COOL MINT TABLETS

MAXIMUM STRENGTH


™


0140068-01
















Zantac 150 Cool Mint 24ct Carton03.14.19

ZAN_150_CoolMint_24ct_CTN_0140068-01_Mex_2019_FDA_DSN




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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




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



MAXIMUM STRENGTH

COOL MINT TABLETS


Releases a

Throatin Mouth &

Cooling Sensation

TABLETS(32 DOSES)24SUGAR

FREE

COOL MINT TABLETS

MAXIMUM STRENGTH


™


0140075-01

















32

Zantac 150 Cool Mint 32ct Carton03.06.19

ZAN_150_CoolMint_32ct_Bonus_CTN_0140075-01_Mex_2019_FDA_DSN2




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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




150Ranitidine Tablets 150 mg/Acid Reducer

COOL MINT TABLETS

MAXIMUM STRENGTH






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


TABLETS

(40 DO

SES)40

Releases a

Throatin Mouth &

Cooling Sensation

™


0140063-01









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






ZAN_150_Coolmint_40ct_CTN_0140063-01_MEX_2019_FDA_DSN.ai02.28.19

Zantac 150 Coolmint 40ct Carton




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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES





COOL MINT TABLETS

MAXIMUM STRENGTH






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


TABLETS

(50 DO

SES)50

Releases a

Throatin Mouth &

Cooling Sensation

™


0140067-01
















ZAN_150_CoolMint_50ct_CTN_0140067-01_Mex_2019_FDA_DSN03.14.19





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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES





COOL MINT TABLETS

MAXIMUM STRENGTH






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


TABLETS

(65 DO

SES)65

Releases a

Throatin Mouth &

Cooling Sensation

™


0140066-01
















ZAN_150_Coolmint_65ct_CTN_0140066-01_Mex_2019_FDA_DSN03.14.19





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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




150

COOL MINT TABLETS

MAXIMUM STRENGTH


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


FREE 78

COOL MINT TABLETS

MAXIMUM STRENGTH

MA

XIM

UM

STRENG

TH


™

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



150150


0140065-01
















ZAN_150_Coolmint_78ct_Bonus_CTN_0140065-01_Mex_2019_FDA_DSN03.14.19





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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




150

COOL MINT TABLETS

MAXIMUM STRENGTH


MA

XIM

UM

STR

ENG

TH


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


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

™


CO

OL

MIN

T TA

BLE

TSCO

OL M

INT TA

BLETS

150150


0140064-01
















ZAN_150_Coolmint_90ct_Value_CTN_0140064-01_Mex_2019_FDA_DSN03.14.19





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




Hairlines:


Horizontal Scale:

Barlines:






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:




Bullets

Body Text

Subheadings

Headings


Drug Facts (Title)

YES




--------------------------------------------------------------------------------------------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


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Zantac 150 3ct Carton 06.13 › drugsatfda_docs › label › 2019 › 02… · MORE TIPS ON BOTTOM...

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Transcript of Zantac 150 3ct Carton 06.13 › drugsatfda_docs › label › 2019 › 02… · MORE TIPS ON BOTTOM...