ANTI-DIARRHEAL LOPERAMIDE HCL- loperamide hydrochloride capsule, liquid filled

Anti-Diarrheal by

Drug Labeling and Warnings

Anti-Diarrheal by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Loperamide HCI 2 mg

Purpose

Anti- diarrheal

Use

controls symptoms of diarrhea, including Traveler's 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
• in children under 12 years of age (see Other information )

Ask a doctor before use if you have

• 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 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
• not for use in children under 12 years of age
• adults and children 12 years of age and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other information

• do not use if carton or blister unit is open or torn
• store at 20o-25o C (68o-77o F)
• avoid excessive heat above 40°C (104°F).
• see side panel for lot number and expiration date
• use the 1 mg soft gelatin capsule product for children 6 to under 12 years of age

Inactive Ingredients

butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil and purified water.

Questions or comments?

call toll free 1-800-447-1140

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT OF IMODIUM® A-D **

A-D

Anti-Diarrheal

Soft Gelatin Capsules, 2mg

Loperamide HCl

Controls the symptoms of diarrhea

Suitable for adults and children 12 years and over

24 SOFTGELS*

*each liquid-capsule contains 2 mg Loperamide HCl

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

**This product is not manufactured or distributed by McNeil Consumer and Specialty Pharmaceuticals, owner of the registered trademark of Imodium® A-D.

Proudly distributed by

Western family foods, Inc

PO Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Product Label

Loperamide HCl 2 mg

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL  LOPERAMIDE HCL
loperamide hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-520
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	P13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-520-24	2 in 1 BOX	07/05/2010	12/31/2020
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021855	07/05/2010	12/31/2020

Labeler - Western Family Foods, Inc. (192166072)