Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Antidiarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

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

Do not use

if you have bloody or black stool

Ask a doctor before use if you have

high 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 buldging. 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 chat. If possible, use weight to dose; otherwise, use age.

adults and children 12 years and older	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 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 at controlled room temperature 20º-25ºC (68º-77ºF)
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 or comments?

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

Principal Display Panel

NDC 21130-291-08
Compare to Imodium® A-D active ingredient†

Anti-Diarrheal
Loperamide HCl, USP 2 mg
• Controls the Symptoms of Diarrhea

48 CAPLETS

SAFEWAY™

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Imodium® A-D.

50844 REV0112C37522

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Safeway 44-375

ANTI-DIARRHEAL
loperamide hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:21130-375
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	44;375
Contains

Packaging
#	Item Code	Package Description
1	NDC:21130-375-22	1 in 1 CARTON
1		48 in 1 BOTTLE

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

Labeler - Safeway (009137209)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(21130-375)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(21130-375)

Revised: 10/2012

Document Id: fc67aa97-8741-4f2f-9bbb-2e7d166e71cd

Set id: 8d3ccda2-3886-4ff7-ad10-6440fc4da6bf

Version: 1

Effective Time: 20121005

Safeway