Caplets* XXXXXXXX Allergy alert: Do not use Ask a doctor ......HelveticaDF-Cond Medium, Cond Bold,...

9
HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic 9.00 8.00 6.00 6.00 6.50 8.00 5.00 2.50 0.50 75% 0 Distributed by: JOHNSON & JOHNSON CONSUMER INC. McNeil Consumer Healthcare Division Fort Washington, PA 19034 USA ©J&JCI 20XX www.imodium.com U.S. Patent No. 6,103,260 ® How can we help? 1-877-895-3665 Loperamide HCl, 2 mg /Simethicone, 125 mg Antidiarrheal/Anti-gas ® Caplet Multi-Symptom Relief • Cramps & Pressure • Bloating • Gas Relieves symptoms of diarrhea plus *capsule-shaped tablets Actual Size TEAR OFF A SECTION 1 FOLD AND TEAR AT NOTCH 2 4 Caplets* Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Heart alert: Taking more than directed can cause serious heart problems or death Do not use ■ if you have bloody or black stool ■ if you have difficulty swallowing Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas Active ingredients (in each caplet) Purposes Loperamide HCl 2 mg………..................................…........... Anti-diarrheal Simethicone 125 mg…………………………................................... Anti-gas Drug Facts Ask a doctor before use if you have ■ fever ■ mucus in the stool ■ a history of iver disease ■ a history of abnormal heart rhythm 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. (1-800-222-1222) Drug Facts (continued) Stop use and ask a doctor if ■ symptoms get worse ■ diarrhea lasts for more than 2 days ■ you get abdominal swel ing or bulging. These may be signs of a serious condition. ■ you have difficulty swallowing the caplet Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs. Other information ■ each caplet contains: calcium 165 mg, sodium 3 mg ■ store between 20-25°C (68-77°F). Protect from ight. ■ do not use if carton is open or if blister unit is open or torn Directions ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea ■ take only on an empty stomach (1 hour before or 2 hours after a meal) ■ take with a full (8 oz.) glass of water ■ find right dose on chart below. f possible, use weight to dose; otherwise, use age. When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours ask a doctor adults and children 12 years and over children 9-11 years (60-95 lbs) children 6-8 years (48-59 lbs) children 2-5 years (34 to 47 lbs) do not use children under 2 years (up to 33 lbs) Inactive ingredients acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid Drug Facts (continued) Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) xxxxxxxx LOT EXP NDC 50580-338-XX 3 0045-0212-12 2 XXXXXXXX XXXXXXXX XXXXXXXX FDASubmissionArtwork_401210278_IMODIUM_MSR_4ct_CARTON_R2.pdf 1 11/27/18 1:34 PM Reference ID: 4361589

Transcript of Caplets* XXXXXXXX Allergy alert: Do not use Ask a doctor ......HelveticaDF-Cond Medium, Cond Bold,...

Page 1: Caplets* XXXXXXXX Allergy alert: Do not use Ask a doctor ......HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic 9.00 8.00 6.00 6.00 6.50 8.00 5.00 2.50 0.50 75% 0 Distributed by:

HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic

9.008.006.00

6.006.508.00

5.002.500.50

75%

0

Distributed by:JOHNSON & JOHNSON CONSUMER INC.McNeil Consumer Healthcare DivisionFort Washington, PA 19034 USA©J&JCI 20XXwww.imodium.comU.S. Patent No. 6,103,260

®

How

can we help?

1-877-895-3665

Loperamide HCl, 2 m

g /Simethicone, 125 m

g Antidiarrheal/Anti-gas

®

Caplet

Multi-Sym

ptom

Relief

• Cram

ps & Pressure

• Bloating • G

as

Relieves sym

pto

ms

of d

iarrhea p

lus

*capsule-shaped tabletsActual Size

TEAR OFF A SECTION

1

FOLD AND TEAR AT NOTCH

2

4 C

aplets*

War

nings

Alle

rgy a

lert:

Do n

ot us

e if y

ou ha

ve ev

er ha

d a ra

sh or

othe

r alle

rgic

reacti

on to

lope

ramide

HCl

Hear

t ale

rt: Ta

king m

ore th

an di

rected

can c

ause

serio

us he

art

prob

lems o

r dea

thDo

not u

se

�

if yo

u hav

e bloo

dy or

blac

k stoo

l

� if

you h

ave d

ifficu

lty sw

allow

ing

Uses

relie

ves s

ympto

ms of

diar

rhea

plus

bloa

ting,

press

ure an

d cra

mps,

comm

only

refer

red to

as ga

s

Activ

e ing

redie

nts (

in ea

ch ca

plet)

Pur

pose

sLo

peram

ide H

Cl 2

mg…

……

........

........

........

........

..…....

.......

Anti-

diarrh

eal

Simeth

icone

125 m

g……

……

……

……

……

........

........

........

........

...An

ti-ga

s

Drug

Fact

s

Ask a

doct

or be

fore

use i

f you

have

�

feve

r

�

muc

us in

the s

tool

� a

histor

y of i

ver d

iseas

e

� a

histor

y of a

bnor

mal h

eart

rhythm

If pr

egna

nt or

brea

st-fe

edin

g, as

k a he

alth p

rofes

siona

l befo

re us

e. Ke

ep ou

t of r

each

of ch

ildre

n. In

case

of ov

erdo

se, g

et me

dical

help

or co

ntact

a Pois

on C

ontro

l Cen

ter rig

ht aw

ay. (1

-800

-222-1

222)

Drug

Fact

s (co

ntinu

ed)

Stop

use a

nd as

k a do

ctor

if

� sy

mptom

s get

worse

� di

arrh

ea la

sts fo

r more

than

2 da

ys�

you g

et ab

domi

nal s

welin

g or b

ulging

. The

se m

ay be

sign

s of a

se

rious

cond

ition.

� yo

u hav

e diffi

culty

swall

owing

the c

aplet

Ask a

docto

r or p

harm

acist

befo

re us

e if y

ou ar

e tak

ing a

presc

riptio

n drug

. Lop

erami

de m

ay in

terac

t with

certa

in pre

scrip

tion d

rugs.

Othe

r inf

orma

tion

� ea

ch ca

plet c

ontai

ns: c

alciu

m 16

5 mg,

sodi

um 3

mg

�

store

betw

een 2

0-25

°C (6

8-77°

F). P

rotec

t from

ight.

�

do no

t use

if ca

rton i

s ope

n or i

f blis

ter u

nit i

s ope

n or t

orn

Dire

ction

s �

drin

k ple

nty o

f cle

ar fl

uids

to he

lp pr

even

t deh

ydra

tion

caus

ed by

diar

rhea

� ta

ke on

ly on

an em

pty st

omac

h (1 h

our b

efore

or 2 h

ours

after

a mea

l)�

take

with

a ful

l (8 oz

.) glas

s of w

ater

� fin

d righ

t dos

e on c

hart

below

. f po

ssibl

e, us

e weig

ht to

dose

; oth

erwi

se, u

se ag

e.

Whe

n usin

g thi

s pro

duct

tiredn

ess,

drows

iness

or di

zzine

ss m

ay

occu

r. Be c

areful

whe

n driv

ing or

oper

ating

mac

hiner

y.

2 cap

lets a

fter th

e firs

t loos

e stoo

l; 1 c

aplet

after

each

subs

eque

nt loo

se st

ool;

but n

o more

than

4 ca

plets

in 24

hour

s1 c

aplet

after

the f

irst lo

ose s

tool;

½ ca

plet a

fter e

ach s

ubse

quen

t loos

e stoo

l; bu

t no m

ore th

an 3

caple

ts in

24 ho

urs

1 cap

let af

ter th

e firs

t loos

e stoo

l; ½

caple

t afte

r eac

h sub

sequ

ent lo

ose s

tool;

but n

o more

than

2 ca

plets

in 24

hour

sas

k a do

ctor

adult

s and

child

ren

12 ye

ars a

nd ov

er

child

ren 9-

11 ye

ars

(60-9

5 lbs

)

child

ren 6-

8 yea

rs (48

-59 l

bs)

child

ren 2-

5 yea

rs(34

to 47

lbs)

do no

t use

child

ren un

der 2

year

s(up

to 33

lbs)

Inac

tive i

ngre

dient

sac

esulf

ame p

otass

ium, c

rosc

arme

llose

sodiu

m, di

basic

calci

um

phos

phate

, flav

or, m

icroc

rystal

line c

ellulo

se, s

tearic

acid

Drug

Fact

s (co

ntinu

ed)

Ques

tions

or co

mmen

ts?

call 1

-877

-895

-366

5 (to

ll-fre

e) o

r 215

-273

-875

5 (c

olle

ct)

xxxxxxxx

LOT

EXP

ND

C 5

05

80

-33

8-X

X

3

0045-0212-12 2

XXXXXXXX

XXXXXXXX

XXXXXXXX

FDASubmissionArtwork_401210278_IMODIUM_MSR_4ct_CARTON_R2.pdf 1 11/27/18 1:34 PM

Reference ID: 4361589

Page 2: Caplets* XXXXXXXX Allergy alert: Do not use Ask a doctor ......HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic 9.00 8.00 6.00 6.00 6.50 8.00 5.00 2.50 0.50 75% 0 Distributed by:

HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic

9.008.006.00

6.006.508.00

5.002.500.50

75%

0

Distributed by:JOHNSON & JOHNSON CONSUMER INC.McNeil Consumer Healthcare DivisionFort Washington, PA 19034 USA©J&JCI 20XXwww.imodium.comU.S. Patent No. 6,103,260

®

How

can we help?

1-877-895-3665

Loperamide HCl, 2 m

g /Simethicone, 125 m

g Antidiarrheal/Anti-gas

®

Caplet

Multi-Sym

ptom

Relief

• Cram

ps & Pressure

• Bloating • G

as

Relieves sym

pto

ms

of d

iarrhea p

lus

*capsule-shaped tablets

6 C

aplets*

Actual Size

TEAR OFF A SECTION

1

FOLD AND TEAR AT NOTCH

2

War

nings

Alle

rgy a

lert:

Do n

ot us

e if y

ou ha

ve ev

er ha

d a ra

sh or

othe

r alle

rgic

reacti

on to

lope

ramide

HCl

Hear

t ale

rt: Ta

king m

ore th

an di

rected

can c

ause

serio

us he

art

prob

lems o

r dea

thDo

not u

se

�

if yo

u hav

e bloo

dy or

blac

k stoo

l

� if

you h

ave d

ifficu

lty sw

allow

ing

Uses

relie

ves s

ympto

ms of

diar

rhea

plus

bloa

ting,

press

ure an

d cra

mps,

comm

only

refer

red to

as ga

s

Activ

e ing

redie

nts (

in ea

ch ca

plet)

Pur

pose

sLo

peram

ide H

Cl 2

mg…

……

........

........

........

........

..…....

.......

Anti-

diarrh

eal

Simeth

icone

125 m

g……

……

……

……

……

........

........

........

........

...An

ti-ga

s

Drug

Fact

s

Ask a

doct

or be

fore

use i

f you

have

�

feve

r

�

muc

us in

the s

tool

� a

histor

y of i

ver d

iseas

e

� a

histor

y of a

bnor

mal h

eart

rhythm

If pr

egna

nt or

brea

st-fe

edin

g, as

k a he

alth p

rofes

siona

l befo

re us

e. Ke

ep ou

t of r

each

of ch

ildre

n. In

case

of ov

erdo

se, g

et me

dical

help

or co

ntact

a Pois

on C

ontro

l Cen

ter rig

ht aw

ay. (1

-800

-222-1

222)

Drug

Fact

s (co

ntinu

ed)

Stop

use a

nd as

k a do

ctor

if

� sy

mptom

s get

worse

� di

arrh

ea la

sts fo

r more

than

2 da

ys�

you g

et ab

domi

nal s

welin

g or b

ulging

. The

se m

ay be

sign

s of a

se

rious

cond

ition.

� yo

u hav

e diffi

culty

swall

owing

the c

aplet

Ask a

docto

r or p

harm

acist

befo

re us

e if y

ou ar

e tak

ing a

presc

riptio

n drug

. Lop

erami

de m

ay in

terac

t with

certa

in pre

scrip

tion d

rugs.

Othe

r inf

orma

tion

� ea

ch ca

plet c

ontai

ns: c

alciu

m 16

5 mg,

sodi

um 3

mg

�

store

betw

een 2

0-25

°C (6

8-77°

F). P

rotec

t from

ight.

�

do no

t use

if ca

rton i

s ope

n or i

f blis

ter u

nit i

s ope

n or t

orn

Dire

ction

s �

drin

k ple

nty o

f cle

ar fl

uids

to he

lp pr

even

t deh

ydra

tion

caus

ed by

diar

rhea

� ta

ke on

ly on

an em

pty st

omac

h (1 h

our b

efore

or 2 h

ours

after

a mea

l)�

take

with

a ful

l (8 oz

.) glas

s of w

ater

� fin

d righ

t dos

e on c

hart

below

. f po

ssibl

e, us

e weig

ht to

dose

; oth

erwi

se, u

se ag

e.

Whe

n usin

g thi

s pro

duct

tiredn

ess,

drows

iness

or di

zzine

ss m

ay

occu

r. Be c

areful

whe

n driv

ing or

oper

ating

mac

hiner

y.

2 cap

lets a

fter th

e firs

t loos

e stoo

l; 1 c

aplet

after

each

subs

eque

nt loo

se st

ool;

but n

o more

than

4 ca

plets

in 24

hour

s1 c

aplet

after

the f

irst lo

ose s

tool;

½ ca

plet a

fter e

ach s

ubse

quen

t loos

e stoo

l; bu

t no m

ore th

an 3

caple

ts in

24 ho

urs

1 cap

let af

ter th

e firs

t loos

e stoo

l; ½

caple

t afte

r eac

h sub

sequ

ent lo

ose s

tool;

but n

o more

than

2 ca

plets

in 24

hour

sas

k a do

ctor

adult

s and

child

ren

12 ye

ars a

nd ov

er

child

ren 9-

11 ye

ars

(60-9

5 lbs

)

child

ren 6-

8 yea

rs (48

-59 l

bs)

child

ren 2-

5 yea

rs(34

to 47

lbs)

do no

t use

child

ren un

der 2

year

s(up

to 33

lbs)

Inac

tive i

ngre

dient

sac

esulf

ame p

otass

ium, c

rosc

arme

llose

sodiu

m, di

basic

calci

um

phos

phate

, flav

or, m

icroc

rystal

line c

ellulo

se, s

tearic

acid

Drug

Fact

s (co

ntinu

ed)

Ques

tions

or co

mmen

ts?

call 1

-877

-895

-366

5 (to

ll-fre

e) o

r 215

-273

-875

5 (c

olle

ct)

xxxxxxxx

LOT

EXP

ND

C 5

05

80

-33

8-X

X

3

0045-0212-12 2

XXXXXXXX

XXXXXXXX

XXXXXXXX

FDASubmissionArtwork_401210279_IMODIUM_MSR_6ct_CARTON_R2.pdf 1 11/27/18 1:10 PM

Reference ID: 4361589

Page 3: Caplets* XXXXXXXX Allergy alert: Do not use Ask a doctor ......HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic 9.00 8.00 6.00 6.00 6.50 8.00 5.00 2.50 0.50 75% 0 Distributed by:

HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic

9.008.006.00

6.006.508.00

5.002.500.50

75%

0

Distributed by:JOHNSON & JOHNSON CONSUMER INC.McNeil Consumer Healthcare DivisionFort Washington, PA 19034 USA©J&JCI 20XXwww.imodium.comU.S. Patent No. 6,103,260

®

How

can we help?

1-877-895-3665

Loperamide HCl, 2 m

g /Simethicone, 125 m

g Antidiarrheal/Anti-gas

®

Caplet

Multi-Sym

ptom

Relief

• Cram

ps & Pressure

• Bloating • G

as

Relieves sym

pto

ms

of d

iarrhea p

lus

*capsule-shaped tablets

8 C

aplets*

Actual Size

TEAR OFF A SECTION

1

FOLD AND TEAR AT NOTCH

2

War

nings

Alle

rgy a

lert:

Do n

ot us

e if y

ou ha

ve ev

er ha

d a ra

sh or

othe

r alle

rgic

reacti

on to

lope

ramide

HCl

Hear

t ale

rt: Ta

king m

ore th

an di

rected

can c

ause

serio

us he

art

prob

lems o

r dea

thDo

not u

se

�

if yo

u hav

e bloo

dy or

blac

k stoo

l

� if

you h

ave d

ifficu

lty sw

allow

ing

Uses

relie

ves s

ympto

ms of

diar

rhea

plus

bloa

ting,

press

ure an

d cra

mps,

comm

only

refer

red to

as ga

s

Activ

e ing

redie

nts (

in ea

ch ca

plet)

Pur

pose

sLo

peram

ide H

Cl 2

mg…

……

........

........

........

........

..…....

.......

Anti-

diarrh

eal

Simeth

icone

125 m

g……

……

……

……

……

........

........

........

........

...An

ti-ga

s

Drug

Fact

s

Ask a

doct

or be

fore

use i

f you

have

�

feve

r

�

muc

us in

the s

tool

� a

histor

y of i

ver d

iseas

e

� a

histor

y of a

bnor

mal h

eart

rhythm

If pr

egna

nt or

brea

st-fe

edin

g, as

k a he

alth p

rofes

siona

l befo

re us

e. Ke

ep ou

t of r

each

of ch

ildre

n. In

case

of ov

erdo

se, g

et me

dical

help

or co

ntact

a Pois

on C

ontro

l Cen

ter rig

ht aw

ay. (1

-800

-222-1

222)

Drug

Fact

s (co

ntinu

ed)

Stop

use a

nd as

k a do

ctor

if

� sy

mptom

s get

worse

� di

arrh

ea la

sts fo

r more

than

2 da

ys�

you g

et ab

domi

nal s

welin

g or b

ulging

. The

se m

ay be

sign

s of a

se

rious

cond

ition.

� yo

u hav

e diffi

culty

swall

owing

the c

aplet

Ask a

docto

r or p

harm

acist

befo

re us

e if y

ou ar

e tak

ing a

presc

riptio

n drug

. Lop

erami

de m

ay in

terac

t with

certa

in pre

scrip

tion d

rugs.

Othe

r inf

orma

tion

� ea

ch ca

plet c

ontai

ns: c

alciu

m 16

5 mg,

sodi

um 3

mg

�

store

betw

een 2

0-25

°C (6

8-77°

F). P

rotec

t from

ight.

�

do no

t use

if ca

rton i

s ope

n or i

f blis

ter u

nit i

s ope

n or t

orn

Dire

ction

s �

drin

k ple

nty o

f cle

ar fl

uids

to he

lp pr

even

t deh

ydra

tion

caus

ed by

diar

rhea

� ta

ke on

ly on

an em

pty st

omac

h (1 h

our b

efore

or 2 h

ours

after

a mea

l)�

take

with

a ful

l (8 oz

.) glas

s of w

ater

� fin

d righ

t dos

e on c

hart

below

. f po

ssibl

e, us

e weig

ht to

dose

; oth

erwi

se, u

se ag

e.

Whe

n usin

g thi

s pro

duct

tiredn

ess,

drows

iness

or di

zzine

ss m

ay

occu

r. Be c

areful

whe

n driv

ing or

oper

ating

mac

hiner

y.

2 cap

lets a

fter th

e firs

t loos

e stoo

l; 1 c

aplet

after

each

subs

eque

nt loo

se st

ool;

but n

o more

than

4 ca

plets

in 24

hour

s1 c

aplet

after

the f

irst lo

ose s

tool;

½ ca

plet a

fter e

ach s

ubse

quen

t loos

e stoo

l; bu

t no m

ore th

an 3

caple

ts in

24 ho

urs

1 cap

let af

ter th

e firs

t loos

e stoo

l; ½

caple

t afte

r eac

h sub

sequ

ent lo

ose s

tool;

but n

o more

than

2 ca

plets

in 24

hour

sas

k a do

ctor

adult

s and

child

ren

12 ye

ars a

nd ov

er

child

ren 9-

11 ye

ars

(60-9

5 lbs

)

child

ren 6-

8 yea

rs (48

-59 l

bs)

child

ren 2-

5 yea

rs(34

to 47

lbs)

do no

t use

child

ren un

der 2

year

s(up

to 33

lbs)

Inac

tive i

ngre

dient

sac

esulf

ame p

otass

ium, c

rosc

arme

llose

sodiu

m, di

basic

calci

um

phos

phate

, flav

or, m

icroc

rystal

line c

ellulo

se, s

tearic

acid

Drug

Fact

s (co

ntinu

ed)

Ques

tions

or co

mmen

ts?

call 1

-877

-895

-366

5 (to

ll-fre

e) o

r 215

-273

-875

5 (c

olle

ct)

xxxxxxxx

LOT

EXP

ND

C 5

05

80

-33

8-X

X

3

0045-0212-12 2

XXXXXXXX

XXXXXXXX

XXXXXXXX

FDASubmissionArtwork_401210460_IMODIUM_MSR_8ct_CARTON_R2.pdf 1 11/27/18 1:19 PM

Reference ID: 4361589

Page 4: Caplets* XXXXXXXX Allergy alert: Do not use Ask a doctor ......HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic 9.00 8.00 6.00 6.00 6.50 8.00 5.00 2.50 0.50 75% 0 Distributed by:

HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic

9.008.006.00

6.006.508.00

5.002.500.50

75%

0

Distributed by:JOHNSON & JOHNSON CONSUMER INC.McNeil Consumer Healthcare DivisionFort Washington, PA 19034 USA©J&JCI 20XXwww.imodium.comU.S. Patent No. 6,103,260

®

How

can we help?

1-877-895-3665

Loperamide HCl, 2 m

g /Simethicone, 125 m

g Antidiarrheal/Anti-gas

®

Caplet

Multi-Sym

ptom

Relief

• Cram

ps & Pressure

• Bloating • G

as

Relieves sym

pto

ms

of d

iarrhea p

lus

*capsule-shaped tablets

12 C

aplets*

Actual Size

TEAR OFF A SECTION

1

FOLD AND TEAR AT NOTCH

2

War

nings

Alle

rgy a

lert:

Do n

ot us

e if y

ou ha

ve ev

er ha

d a ra

sh or

othe

r alle

rgic

reacti

on to

lope

ramide

HCl

Hear

t ale

rt: Ta

king m

ore th

an di

rected

can c

ause

serio

us he

art

prob

lems o

r dea

thDo

not u

se

�

if yo

u hav

e bloo

dy or

blac

k stoo

l

� if

you h

ave d

ifficu

lty sw

allow

ing

Uses

relie

ves s

ympto

ms of

diar

rhea

plus

bloa

ting,

press

ure an

d cra

mps,

comm

only

refer

red to

as ga

s

Activ

e ing

redie

nts (

in ea

ch ca

plet)

Pur

pose

sLo

peram

ide H

Cl 2

mg…

……

........

........

........

........

..…....

.......

Anti-

diarrh

eal

Simeth

icone

125 m

g……

……

……

……

……

........

........

........

........

...An

ti-ga

s

Drug

Fact

s

Ask a

doct

or be

fore

use i

f you

have

�

feve

r

�

muc

us in

the s

tool

� a

histor

y of i

ver d

iseas

e

� a

histor

y of a

bnor

mal h

eart

rhythm

If pr

egna

nt or

brea

st-fe

edin

g, as

k a he

alth p

rofes

siona

l befo

re us

e. Ke

ep ou

t of r

each

of ch

ildre

n. In

case

of ov

erdo

se, g

et me

dical

help

or co

ntact

a Pois

on C

ontro

l Cen

ter rig

ht aw

ay. (1

-800

-222-1

222)

Drug

Fact

s (co

ntinu

ed)

Stop

use a

nd as

k a do

ctor

if

� sy

mptom

s get

worse

� di

arrh

ea la

sts fo

r more

than

2 da

ys�

you g

et ab

domi

nal s

welin

g or b

ulging

. The

se m

ay be

sign

s of a

se

rious

cond

ition.

� yo

u hav

e diffi

culty

swall

owing

the c

aplet

Ask a

docto

r or p

harm

acist

befo

re us

e if y

ou ar

e tak

ing a

presc

riptio

n drug

. Lop

erami

de m

ay in

terac

t with

certa

in pre

scrip

tion d

rugs.

Othe

r inf

orma

tion

� ea

ch ca

plet c

ontai

ns: c

alciu

m 16

5 mg,

sodi

um 3

mg

�

store

betw

een 2

0-25

°C (6

8-77°

F). P

rotec

t from

ight.

�

do no

t use

if ca

rton i

s ope

n or i

f blis

ter u

nit i

s ope

n or t

orn

Dire

ction

s �

drin

k ple

nty o

f cle

ar fl

uids

to he

lp pr

even

t deh

ydra

tion

caus

ed by

diar

rhea

� ta

ke on

ly on

an em

pty st

omac

h (1 h

our b

efore

or 2 h

ours

after

a mea

l)�

take

with

a ful

l (8 oz

.) glas

s of w

ater

� fin

d righ

t dos

e on c

hart

below

. f po

ssibl

e, us

e weig

ht to

dose

; oth

erwi

se, u

se ag

e.

Whe

n usin

g thi

s pro

duct

tiredn

ess,

drows

iness

or di

zzine

ss m

ay

occu

r. Be c

areful

whe

n driv

ing or

oper

ating

mac

hiner

y.

2 cap

lets a

fter th

e firs

t loos

e stoo

l; 1 c

aplet

after

each

subs

eque

nt loo

se st

ool;

but n

o more

than

4 ca

plets

in 24

hour

s1 c

aplet

after

the f

irst lo

ose s

tool;

½ ca

plet a

fter e

ach s

ubse

quen

t loos

e stoo

l; bu

t no m

ore th

an 3

caple

ts in

24 ho

urs

1 cap

let af

ter th

e firs

t loos

e stoo

l; ½

caple

t afte

r eac

h sub

sequ

ent lo

ose s

tool;

but n

o more

than

2 ca

plets

in 24

hour

sas

k a do

ctor

adult

s and

child

ren

12 ye

ars a

nd ov

er

child

ren 9-

11 ye

ars

(60-9

5 lbs

)

child

ren 6-

8 yea

rs (48

-59 l

bs)

child

ren 2-

5 yea

rs(34

to 47

lbs)

do no

t use

child

ren un

der 2

year

s(up

to 33

lbs)

Inac

tive i

ngre

dient

sac

esulf

ame p

otass

ium, c

rosc

arme

llose

sodiu

m, di

basic

calci

um

phos

phate

, flav

or, m

icroc

rystal

line c

ellulo

se, s

tearic

acid

Drug

Fact

s (co

ntinu

ed)

Ques

tions

or co

mmen

ts?

call 1

-877

-895

-366

5 (to

ll-fre

e) o

r 215

-273

-875

5 (c

olle

ct)

xxxxxxxx

LOT

EXP

ND

C 5

05

80

-33

8-12

3

0045-0212-12 2

XXXXXXXX

XXXXXXXX

XXXXXXXX

FDASubmissionArtwork_401210461_IMODIUM_MSR_12ct_CARTON_R2.pdf 1 11/27/18 1:23 PM

Reference ID: 4361589

Page 5: Caplets* XXXXXXXX Allergy alert: Do not use Ask a doctor ......HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic 9.00 8.00 6.00 6.00 6.50 8.00 5.00 2.50 0.50 75% 0 Distributed by:

HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic

9.008.006.00

6.006.508.00

5.002.500.50

75%

0

TEAR OFF A SECTION

1

FOLD AND TEAR AT NOTCH

2

®

How

can we help?

1-877-895-3665

Loperamide HCl, 2 m

g /Simethicone, 125 m

g Antidiarrheal/Anti-gas

®

Caplet

Multi-Sym

ptom

Relief

• Cram

ps & Pressure

• Bloating • G

as

Relieves sym

pto

ms

of d

iarrhea p

lus

Actual Size*capsule-shaped tablets

18 C

aplets*

Distributed by:JOHNSON & JOHNSON CONSUMER INC.McNeil Consumer Healthcare DivisionFort Washington, PA 19034 USA©J&JCI 20XXwww.imodium.comU.S. Patent No. 6,103,260

War

nings

Alle

rgy a

lert:

Do n

ot us

e if y

ou ha

ve ev

er ha

d a ra

sh or

othe

r alle

rgic

reacti

on to

lope

ramide

HCl

Hear

t ale

rt: Ta

king m

ore th

an di

rected

can c

ause

serio

us he

art

prob

lems o

r dea

th

Do no

t use

�

if yo

u hav

e bloo

dy or

blac

k stoo

l

� if

you h

ave d

ifficu

lty sw

allow

ing

Uses

relie

ves s

ympto

ms of

diar

rhea

plus

bloa

ting,

press

ure an

d cra

mps,

comm

only

refer

red to

as ga

s

Activ

e ing

redie

nts (

in ea

ch ca

plet)

Pur

pose

sLo

peram

ide H

Cl 2

mg…

……

........

........

........

........

..…....

.......

Anti-

diarrh

eal

Simeth

icone

125 m

g……

……

……

……

……

........

........

........

........

...An

ti-ga

s

Drug

Fact

s

Ask a

doct

or be

fore

use i

f you

have

�

feve

r

�

muc

us in

the s

tool

� a

histor

y of li

ver d

iseas

e

� a

histor

y of a

bnor

mal h

eart

rhythm

If pr

egna

nt or

brea

st-fe

edin

g, as

k a he

alth p

rofes

siona

l befo

re us

e. Ke

ep ou

t of r

each

of ch

ildre

n. In

case

of ov

erdo

se, g

et me

dical

help

or co

ntact

a Pois

on C

ontro

l Cen

ter rig

ht aw

ay. (1

-800

-222-1

222)

Drug

Fact

s (co

ntinu

ed)

Stop

use a

nd as

k a do

ctor

if

� sy

mptom

s get

worse

�

diar

rhea

lasts

for m

ore th

an 2

days

� yo

u get

abdo

mina

l swe

lling o

r bulg

ing. T

hese

may

be si

gns o

f a

serio

us co

nditio

n.

� yo

u hav

e diffi

culty

swall

owing

the c

aplet

Ask a

docto

r or p

harm

acist

befo

re us

e if y

ou ar

e tak

ing a

presc

riptio

n drug

. Lop

erami

de m

ay in

terac

t with

certa

in pre

scrip

tion d

rugs.

Othe

r inf

orma

tion

� ea

ch ca

plet c

ontai

ns: c

alciu

m 16

5 mg,

sodi

um 3

mg

�

store

betw

een 2

0-25

°C (6

8-77°

F). P

rotec

t from

light.

�

do no

t use

if ca

rton i

s ope

n or i

f blis

ter u

nit i

s ope

n or t

orn

Dire

ction

s �

drin

k ple

nty o

f cle

ar fl

uids

to he

lp pr

even

t deh

ydra

tion

caus

ed by

diar

rhea

� ta

ke on

ly on

an em

pty st

omac

h (1 h

our b

efore

or 2 h

ours

after

a mea

l)�

take

with

a fu

l (8 oz

.) glas

s of w

ater

� fin

d righ

t dos

e on c

hart

below

. f po

ssble

, use

weig

ht to

dose

; oth

erwi

se, u

se ag

e.

Whe

n usin

g thi

s pro

duct

tiredn

ess,

drows

iness

or di

zzine

ss m

ay

occu

r. Be c

areful

whe

n driv

ing or

oper

ating

mac

hiner

y.

2 cap

lets a

fter th

e firs

t loos

e stoo

l; 1 c

aplet

after

each

subs

eque

nt loo

se st

ool;

but n

o more

than

4 ca

plets

in 24

hour

s1 c

aplet

after

the f

irst lo

ose s

tool;

½ ca

plet a

fter e

ach s

ubse

quen

t loos

e stoo

l; bu

t no m

ore th

an 3

caple

ts in

24 ho

urs

1 cap

let af

ter th

e firs

t loos

e stoo

l; ½

caple

t afte

r eac

h sub

sequ

ent lo

ose s

tool;

but n

o more

than

2 ca

plets

in 24

hour

sas

k a do

ctor

adut

s and

child

ren

12 ye

ars a

nd ov

er

child

ren 9-

11 ye

ars

(60-9

5 bs

)

child

ren 6-

8 yea

rs (48

-59 l

bs)

child

ren 2-

5 yea

rs(34

to 47

lbs)

do no

t use

child

ren un

der 2

year

s(up

to 33

lbs)

Inac

tive i

ngre

dient

sac

esulf

ame p

otass

ium, c

rosc

arme

llose

sodiu

m, di

basic

calci

um

phos

phate

, flav

or, m

icroc

rysta

line c

ellulo

se, s

tearic

acid

Drug

Fact

s (co

ntinu

ed)

Ques

tions

or co

mmen

ts?

call 1

-877

-895

-366

5 (to

ll-fre

e) o

r 215

-273

-875

5 (c

olle

ct)

LOT:

EXP:

xxxxxxxx

ND

C 50

580

-338-18

3 0045-0212-18 4

XXXXXXXX

XXXXXXXX

XXXXXXXX

FDASubmissionArtwork_401210462_IMODIUM_MSR_18ct_CARTON_R2.pdf 1 11/27/18 1:30 PM

Reference ID: 4361589

Page 6: Caplets* XXXXXXXX Allergy alert: Do not use Ask a doctor ......HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic 9.00 8.00 6.00 6.00 6.50 8.00 5.00 2.50 0.50 75% 0 Distributed by:

HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic

9.008.006.00

6.006.508.00

5.002.500.50

75%

0

Distributed by:JOHNSON & JOHNSON CONSUMER INC.McNeil Consumer Healthcare DivisionFort Washington, PA 19034 USA©J&JCI 20XXwww.imodium.comU.S. Patent No. 6,103,260

®

How

can we help?

1-877-895-3665

Loperamide HCl, 2 m

g /Simethicone, 125 m

g Antidiarrheal/Anti-gas

®

Caplet

Multi-Sym

ptom

Relief

• Cram

ps & Pressure

• Bloating • G

as

Relieves sym

pto

ms

of d

iarrhea p

lus

*capsule-shaped tablets

24 C

aplets*

Actual Size

TEAR OFF A SECTION

1

FOLD AND TEAR AT NOTCH

2

War

nings

Alle

rgy a

lert:

Do n

ot us

e if y

ou ha

ve ev

er ha

d a ra

sh or

othe

r alle

rgic

reacti

on to

lope

ramide

HCl

Hear

t ale

rt: Ta

king m

ore th

an di

rected

can c

ause

serio

us he

art

prob

lems o

r dea

thDo

not u

se

�

if yo

u hav

e bloo

dy or

blac

k stoo

l

� if

you h

ave d

ifficu

lty sw

allow

ing

Uses

relie

ves s

ympto

ms of

diar

rhea

plus

bloa

ting,

press

ure an

d cra

mps,

comm

only

refer

red to

as ga

s

Activ

e ing

redie

nts (

in ea

ch ca

plet)

Pur

pose

sLo

peram

ide H

Cl 2

mg…

……

........

........

........

........

..…....

.......

Anti-

diarrh

eal

Simeth

icone

125 m

g……

……

……

……

……

........

........

........

........

...An

ti-ga

s

Drug

Fact

s

Ask a

doct

or be

fore

use i

f you

have

�

feve

r

�

muc

us in

the s

tool

� a

histor

y of i

ver d

iseas

e

� a

histor

y of a

bnor

mal h

eart

rhythm

If pr

egna

nt or

brea

st-fe

edin

g, as

k a he

alth p

rofes

siona

l befo

re us

e. Ke

ep ou

t of r

each

of ch

ildre

n. In

case

of ov

erdo

se, g

et me

dical

help

or co

ntact

a Pois

on C

ontro

l Cen

ter rig

ht aw

ay. (1

-800

-222-1

222)

Drug

Fact

s (co

ntinu

ed)

Stop

use a

nd as

k a do

ctor

if

� sy

mptom

s get

worse

� di

arrh

ea la

sts fo

r more

than

2 da

ys�

you g

et ab

domi

nal s

welin

g or b

ulging

. The

se m

ay be

sign

s of a

se

rious

cond

ition.

� yo

u hav

e diffi

culty

swall

owing

the c

aplet

Ask a

docto

r or p

harm

acist

befo

re us

e if y

ou ar

e tak

ing a

presc

riptio

n drug

. Lop

erami

de m

ay in

terac

t with

certa

in pre

scrip

tion d

rugs.

Othe

r inf

orma

tion

� ea

ch ca

plet c

ontai

ns: c

alciu

m 16

5 mg,

sodi

um 3

mg

�

store

betw

een 2

0-25

°C (6

8-77°

F). P

rotec

t from

ight.

�

do no

t use

if ca

rton i

s ope

n or i

f blis

ter u

nit i

s ope

n or t

orn

Dire

ction

s �

drin

k ple

nty o

f cle

ar fl

uids

to he

lp pr

even

t deh

ydra

tion

caus

ed by

diar

rhea

� ta

ke on

ly on

an em

pty st

omac

h (1 h

our b

efore

or 2 h

ours

after

a mea

l)�

take

with

a ful

l (8 oz

.) glas

s of w

ater

� fin

d righ

t dos

e on c

hart

below

. f po

ssibl

e, us

e weig

ht to

dose

; oth

erwi

se, u

se ag

e.

Whe

n usin

g thi

s pro

duct

tiredn

ess,

drows

iness

or di

zzine

ss m

ay

occu

r. Be c

areful

whe

n driv

ing or

oper

ating

mac

hiner

y.

2 cap

lets a

fter th

e firs

t loos

e stoo

l; 1 c

aplet

after

each

subs

eque

nt loo

se st

ool;

but n

o more

than

4 ca

plets

in 24

hour

s1 c

aplet

after

the f

irst lo

ose s

tool;

½ ca

plet a

fter e

ach s

ubse

quen

t loos

e stoo

l; bu

t no m

ore th

an 3

caple

ts in

24 ho

urs

1 cap

let af

ter th

e firs

t loos

e stoo

l; ½

caple

t afte

r eac

h sub

sequ

ent lo

ose s

tool;

but n

o more

than

2 ca

plets

in 24

hour

sas

k a do

ctor

adult

s and

child

ren

12 ye

ars a

nd ov

er

child

ren 9-

11 ye

ars

(60-9

5 lbs

)

child

ren 6-

8 yea

rs (48

-59 l

bs)

child

ren 2-

5 yea

rs(34

to 47

lbs)

do no

t use

child

ren un

der 2

year

s(up

to 33

lbs)

Inac

tive i

ngre

dient

sac

esulf

ame p

otass

ium, c

rosc

arme

llose

sodiu

m, di

basic

calci

um

phos

phate

, flav

or, m

icroc

rystal

line c

ellulo

se, s

tearic

acid

Drug

Fact

s (co

ntinu

ed)

Ques

tions

or co

mmen

ts?

call 1

-877

-895

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FDASubmissionArtwork_401210463_IMODIUM_MSR_24ct_CARTON_R2.pdf 1 11/27/18 1:41 PM

Reference ID: 4361589

Page 7: Caplets* XXXXXXXX Allergy alert: Do not use Ask a doctor ......HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic 9.00 8.00 6.00 6.00 6.50 8.00 5.00 2.50 0.50 75% 0 Distributed by:

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

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Antidiarrheal/A

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HC

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Sim

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cone

125

mg

per c

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1 CAP

LET

Ant

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as

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HC

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let

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cone

125

mg

per c

aple

t

1 CAP

LET

Ant

idia

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al/A

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as

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

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nti-Gas

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

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ide

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per c

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LET

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idia

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CI 2 m

g per caplet• S

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g per caplet

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CI 2 m

g per caplet• S

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ide

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CI 2 m

g per caplet S

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g per caplet

1 CAPLET

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• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Lop

eram

ide

HC

I 2 m

g pe

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CAP

LET

Ant

idia

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al/A

nti-G

as

• Lop

eram

ide

HC

I 2 m

g pe

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CAP

LET

Ant

idia

rrhe

al/A

nti-G

as

• Loperamide H

CI 2 m

g per caplet S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Lop

eram

ide

HC

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g pe

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let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CAP

LET

Ant

idia

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al/A

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as

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ide

HC

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let

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ethi

cone

125

mg

per c

aple

t

1 CAP

LET

Ant

idia

rrhe

al/A

nti-G

as

• Loperamide H

CI 2 m

g per caplet S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Lop

eram

ide

HC

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g pe

r cap

let

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ethi

cone

125

mg

per c

aple

t

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LET

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idia

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ide

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let

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ethi

cone

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per c

aple

t

1 CAP

LET

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idia

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imethicone 125 m

g per caplet

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pe caplet

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plet

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Antidiarrheal/A

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eram

ide

HC

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r cap

let

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ethi

cone

125

mg

per c

aple

t

1 CAP

LET

Ant

idia

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as

Lop

eam

ide

HC

I 2 m

g pe

r cap

let

Sm

thic

one

125

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per c

aple

t

1 CAP

LET

Ant

idia

rrhe

al/A

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as

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Lop

eram

ide

HC

I 2 m

g pe

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CAP

LET

Ant

idia

rrhe

al/A

nti-G

as

• Lop

eram

ide

HC

I 2 m

g pe

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CAP

LET

Ant

idia

rrhe

al/A

nti-G

as

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

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• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Lop

eram

ide

HC

I 2 m

g pe

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CAP

LET

Ant

idia

rrhe

al/A

nti-G

as

• Lop

eram

ide

HC

I 2 m

g pe

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CAP

LET

Ant

idia

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al/A

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TEA

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TCH

Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNel Consumer Healthcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 20XX

Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNel Consumer Healhcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 20XX

Dist.

by: J

OHNS

ON &

JOHN

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McNel Consumer Healthcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 20XX

Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNel Consumer Healhcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 20XX

Dist.

by: J

OHNS

ON &

JOHN

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INC.

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNel Consumer Healthcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 20XX

Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNel Consumer Healhcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 20XX

Dist.

by: J

OHNS

ON &

JOHN

SON

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INC.

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©J&J

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McNel Consumer Healthcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 20XX

Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 20XX

Dist.

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ON &

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SON

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNel Consumer Healthcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 20XX

Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 20XX

Dist.

by: J

OHNS

ON &

JOHN

SON

CONS

UMER

INC.

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Fort W

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FDA_Submission_Artwork_XXXXXXXX_IMODIUM_MULTI-SYMPTOM_RELIEF_BLISTER_R1.pdf 1 4/11/18 8:32 AM

Reference ID: 4361589

(b) (4)

Page 8: Caplets* XXXXXXXX Allergy alert: Do not use Ask a doctor ......HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic 9.00 8.00 6.00 6.00 6.50 8.00 5.00 2.50 0.50 75% 0 Distributed by:

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

nti-Gas

• Lop

eram

ide

HC

I 2 m

g pe

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CA

PLET

Ant

idia

rrhe

al/A

nti-G

as

• Lop

eram

ide

HC

I 2 m

g pe

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let

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cone

125

mg

per c

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t

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per c

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Ant

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al/A

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g per caplet• S

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g per caplet

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CI 2 m

g per caplet• S

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g per caplet

1 CAPLET

Antidiarrheal/A

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• Loperamide H

CI 2 m

g per caplet• S

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g per caplet

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Antidiarrheal/A

nti-Gas

• Lop

eram

ide

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let

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ethi

cone

125

mg

per c

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t

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let

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Ant

idia

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g per caplet• S

imethicone 125 m

g per caplet

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CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

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g per caplet• S

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g per caplet

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ide

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let

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare DivisionFort W

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNel Consumer Healthcare DivisionFort W

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

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ashington, PA 19034 USA ©J&JCI 2016

Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Heathcare DivisionFort W

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNel Consumer Healthcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 2016

Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Heathcare DivisionFort W

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNel Consumer Healthcae DivisionFort W

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNel Consumer Healthcare DivisionFort W

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

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McNeil Consumer Healthcare DivisionFort W

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Reference ID: 4361589

(b) (4)

Page 9: Caplets* XXXXXXXX Allergy alert: Do not use Ask a doctor ......HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic 9.00 8.00 6.00 6.00 6.50 8.00 5.00 2.50 0.50 75% 0 Distributed by:

--------------------------------------------------------------------------------------------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 PRATT12/11/2018

Signature Page 1 of 1

Reference ID: 4361589


Gold Star Champions Euan Thorburn/Paul Beaton on the Nicky ... · Duncan Wild 8.00 A 10.00 A 10.00 A 28.00 Abbie McGuinness U 10.00 E 6.00 E 8.89 E 24.89 Amy Baines U 6.67 E 8.00

Gold Star Champions Euan Thorburn/Paul Beaton on the Nicky ... · Duncan Wild 8.00 A 10.00 A 10.00 A 28.00 Abbie McGuinness U 10.00 E 6.00 E 8.89 E 24.89 Amy Baines U 6.67 E 8.00

AN 1 - IOPRI · Time Ac TiviTy SuNdAy 12 NOVember 2017 8.00 am Golf 8.00 am – 6.00 pm Congress pre- registration 2.30 pm – 6.00 pm Technical tour registration mONdAy 13 NOVember

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RAINIERTENTS2le0xp15a8jj172v473v3y381vh.wpengine.netdna-cdn.com/...6" Clear Prismatic 780035 $6.00 6" White 780036 $6.00 8" White 780037 $8.00 10" White 707005 $10.00 12" White 707006

RAINIERTENTS2le0xp15a8jj172v473v3y381vh.wpengine.netdna-cdn.com/...6" Clear Prismatic 780035 $6.00 6" White 780036 $6.00 8" White 780037 $8.00 10" White 707005 $10.00 12" White 707006

Menu · 2019-11-12 · Sun-dried tomato & spinach risotto 10oz gammon steak Grilled pineapple, one fried egg, thick cut chips £6.00 £8.00 £7.00 £7.00 £6.00 £5.00 Salads Add

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WELCOME TO THE BOX TREE AA NOTABLE WINE LIST 2018 …famous grouse 40 £5.50 chivas regal 40 £6.00 elija craig 12 years old 45 £8.00 chapter 14 (not peated), england 46 £8.00 laphroaig

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desserts - China Paleis · 2020. 6. 15. · Desserts € Coupe China Paleis.....8.00 Coupe vanille.....6.00 Coupe aardbeien.....

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Health Financial Systems In Lieu of Form CMS-2552-10 ST ......6.00 swing bed - nf 0 0 6.00 7.00 skilled nursing facility 0 0 0 0 7.00 8.00 nursing facility 0 0 8.00 9.00 home health

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WINE & DRINKS...Remy Martin VSOP 8.00 Remy Martin XO 12.00 Vieux Dujardin 6.00 Jack Daniels 6.50 Jameson 6.00 Four Roses Bourbon 6.00 Glenfiddich 8.50 Tequila Patron 7.00 …

WINE & DRINKS...Remy Martin VSOP 8.00 Remy Martin XO 12.00 Vieux Dujardin 6.00 Jack Daniels 6.50 Jameson 6.00 Four Roses Bourbon 6.00 Glenfiddich 8.50 Tequila Patron 7.00 …

TCD - 6pp DL - Discover brochure 03 flyer-FINAL.pdf · Dawson St. 6.00 – 8.00 pm 6.00 – 11.00 pm Biodiversity Jungle of Knowledge EU House on Dawson St. 4.00 – 8.00 pm Digital

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MH SERIES TAB - Bimba · MP1 MP2 1.50”-8.00” Bores 1.50”-6.00” Bores SB 1.50”-8.00” Bores HH - Heavy Duty Hydraulic HH Rod Lock MH - Medium Duty Hydraulic MH Options TAS

MH SERIES TAB - Bimba · MP1 MP2 1.50”-8.00” Bores 1.50”-6.00” Bores SB 1.50”-8.00” Bores HH - Heavy Duty Hydraulic HH Rod Lock MH - Medium Duty Hydraulic MH Options TAS

E.P. FARMACIA Y BIOQUfMICA - unjbg.edu.pe · 1 Acido urico en orina de 24 horas 8.00 8.00 2 Depuraci6n de creatinina 10.00 8.00 3 Diagn6stico de embarazo 6.00 5.00 ... THEVENON 5.00

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WHAT S TO EAT & DRINK? - Hilton Bonnet Creek...Shaved parmigiano-reggiano, ciabatta crostini Small $8.00 Large $10.00 Add Grilled Chicken $6.00 Add Shrimp $8.00 Garden Chop Tomatoes,

WHAT S TO EAT & DRINK? - Hilton Bonnet Creek...Shaved parmigiano-reggiano, ciabatta crostini Small $8.00 Large $10.00 Add Grilled Chicken $6.00 Add Shrimp $8.00 Garden Chop Tomatoes,

Hoffman Specifier's Guide, Vol. 21, 2007 · F44XGV 4.00 x 4.00 (102 x 102) 11.85 301 F66XGV 6.00 x 6.00 (152 x 152) 13.85 352 F88XGV 8.00 x 8.00 (203 x 203) 15.84 402 F1010XGV 10.00

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crocks weekend salads - smiths-restaurant.comsandwiches chipotle aioli 8.00 **steamed edamame 6.00 pickles, dill mayonaisse chimichurri sauce 9.00 crispy coconut shrimp spicy tzatziki

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CHURCH CLEANING: 31ST SUNDAY IN ORDINARY TIME · 2021. 5. 2. · 31ST SUNDAY IN ORDINARY TIME 4TH NOVEMBER, 2018 (YEAR B) MASS TIMES 6.00 pm 8.00 am 9.30 am 11.00 am 6.00 pm LECTOR

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2BD Series e-1532...9.70 (246) 6.00 (152) 4.38 (111) 17.00 (432) 0.00 (0) 8.00 (203) 326jm 11.00 (279) 15.13 (384) 15.50 (394) 36.13 (918) 8.00 (203) 12.00 (305) 0.69 (18) 0.75 (19)

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- WIL-W - Science...HOTEL RESERVATIONS AAAS CENTENNIAL CELEBRATION September 13-17, 1948 HOTEL LOCATION RATES SINGLE DOUBLE AMBASSADOR 14th and KSts, NW $3.50-8.00 $6.00-8.00 ANNAPOLIS

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Iced Co˜ee, with BIONIS YE DRK NS11.45 8.00 0.00 1.14 0.15 0.00 100.00 8.00 79.26 11.45 6.00 1.90 1.14 0.15 0.10 100.00 6.00 Milk Powder Water Sugar Maltodextrin Instant Co˜ee Powder

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EDGAR · PDF fileEDGAR® Pro enables investors, analysts, ... $14.00 12.00 10.00 8.00 6.00 FORD MTR CO DEL ... Filing Agent RR DONNELLEY FILE 16

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