ANTI-DIARRHEAL- loperamide hydrochloride tablet
WALGREEN CO.

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Active ingredient(s)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use(s)

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use

if you have bloody or black stool

Ask a doctor before use if you have

a fever
mucus in the stool
a history of liver disease

Ask a doctor or pharmacist before use if you are

taking antibiotics

When using this product

tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

symptoms get worse
diarrhea lasts for more than 2 days
you get abdominal swelling or bulging. These may be signs of a serious condition.

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

drink plenty of clear fluids to help prevent dehydration caused by diarrhea
find right dose on chart. If possible, use weight to dose; otherwise, use age.

adults and children 12 years and over	2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours
children 9-11 years (60-95 lbs)	1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours
children 6-8 years (48-59 lbs)	1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs)	ask a doctor

Other information

store between 20°-25°C (68°-77°F)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C blue #1 brilliant blue lake, magnesium stearate, microcrystalline cellulose, silica gel

Questions

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

NDC 0363-0375-08

Compare to Imodium® A-D

active ingredient**

Walgreens

ANTI-

DIARRHEAL

Loperamides HCl

THIS PACKAGE NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

Controls the Symptoms of Diarrhea

Easy to Swallow

Caplets

24 CAPLETS*

*Each caplet (capsule-shaped tablet) contains 2 mg loperamide HCl

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

50844 REV0710G37508

Distributed by: Walgreen Co.,

200 Wilmot Rd., Deerfield, IL 60015-4616

Product Packaging

ANTI-DIARRHEAL
loperamides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0375
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE)	LOPERAMIDE HYDROCHLORIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE

Product Characteristics
Color	GREEN (Light Green)	Score	2 pieces
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	44;375
Contains

Packaging
#	Item Code	Package Description
1	NDC:0363-0375-08	1 in 1 CARTON
1		24 in 1 BLISTER PACK
2	NDC:0363-0375-11	1 in 1 CARTON
2		60 in 1 BLISTER PACK
3	NDC:0363-0375-22	1 in 1 CARTON
3		48 in 1 BLISTER PACK
4	NDC:0363-0375-45	1 in 1 CARTON
4		6 in 1 BLISTER PACK
5	NDC:0363-0375-46	1 in 1 CARTON
5		96 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076497	05/03/2005

Labeler - WALGREEN CO. (008965063)

Revised: 08/2011

Document Id: d8fb1612-f904-499a-a5cf-63ee74fb96e5

Set id: 31f9b652-e9c9-46ed-a46c-22d30ad11004

Version: 4

Effective Time: 20110817

WALGREEN CO.