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

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

Reference ID: 4361589

9.008.006.00

6.006.508.00

5.002.500.50

75%

0

®

How

can we help?

1-877-895-3665

Loperamide HCl, 2 m

®

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

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

9.008.006.00

6.006.508.00

5.002.500.50

75%

0

®

How

can we help?

1-877-895-3665

Loperamide HCl, 2 m

®

Caplet

Multi-Sym

ptom

Relief

• Cram

ps & Pressure

• Bloating • G

as

Relieves sym

pto

ms

of d

iarrhea p

lus

8 C

aplets*

Actual Size

TEAR OFF A SECTION

1

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

9.008.006.00

6.006.508.00

5.002.500.50

75%

0

®

How

can we help?

1-877-895-3665

Loperamide HCl, 2 m

®

Caplet

Multi-Sym

ptom

Relief

• Cram

ps & Pressure

• Bloating • G

as

Relieves sym

pto

ms

of d

iarrhea p

lus

12 C

aplets*

Actual Size

TEAR OFF A SECTION

1

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

9.008.006.00

6.006.508.00

5.002.500.50

75%

0

TEAR OFF A SECTION

1

2

®

How

can we help?

1-877-895-3665

Loperamide HCl, 2 m

®

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*

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

9.008.006.00

6.006.508.00

5.002.500.50

75%

0

®

How

can we help?

1-877-895-3665

Loperamide HCl, 2 m

®

Caplet

Multi-Sym

ptom

Relief

• Cram

ps & Pressure

• Bloating • G

as

Relieves sym

pto

ms

of d

iarrhea p

lus

24 C

aplets*

Actual Size

TEAR OFF A SECTION

1

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

• 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

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

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

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

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

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

Antidiarrheal/A

nti-Gas

• Loperamide H

CI 2 m

pe caplet

• Sim

ethicone 125 mg p

plet

1 CAPLET

Antidiarrheal/A

ntiG

• 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

eam

ide

HC

I 2 m

g pe

r cap

let

Sm

thic

one

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

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

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

• Lop

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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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LET

Ant

idia

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al/A

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Dist. by: JOHNSON & JOHNSON CONSUMER INC.

McNel Consumer Healthcare DivisionFort W

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xxxxxxxx

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

(b) (4)

• 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

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

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CA

PLET

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

• 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

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

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CA

PLET

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

• 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

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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 CA

PLET

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 CA

PLET

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

• 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

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

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CA

PLET

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

• 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

• Sim

ethi

cone

125

mg

per c

aple

t

1 CA

PLET

Ant

idia

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al/A

nti-G

as

• Lop

eram

ide

HC

I 2 m

g pe

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let

• Sim

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cone

125

mg

per c

aple

t

1 CA

PLET

Ant

idia

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al/A

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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

• 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

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let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CA

PLET

Ant

idia

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al/A

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as

• Lop

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ide

HC

I 2 m

g pe

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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

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CA

PLET

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

pe caplet

• Sim

ethicone 125 mg p

plet

1 CAPLET

Antidiarrheal/A

ntiG

• Loperamide H

CI 2 m

g per caplet• S

imethicone 125 m

g per caplet

1 CAPLET

Antidiarrheal/A

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Lop

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HC

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Sim

thic

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125

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per c

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Ati

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l/Ant

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• Lop

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ide

HC

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g pe

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let

• Sim

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cone

125

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per c

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PLET

Ant

idia

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al/A

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Lop

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ide

HC

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Sm

thic

one

125

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per c

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1 CA

PLET

Ant

idia

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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

• 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

r cap

let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CA

PLET

Ant

idia

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al/A

nti-G

as

• Lop

eram

ide

HC

I 2 m

g pe

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let

• Sim

ethi

cone

125

mg

per c

aple

t

1 CA

PLET

Ant

idia

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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

• 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

• Sim

ethi

cone

125

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per c

aple

t

1 CA

PLET

Ant

idia

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al/A

nti-G

as

• Lop

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HC

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4A

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30036937

(b) (4)

--------------------------------------------------------------------------------------------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/------------------------------------------------------------

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