ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled

Anti-Diarrheal by

Drug Labeling and Warnings

Anti-Diarrheal by is a Otc medication manufactured, distributed, or labeled by Care One (American Sales Company), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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.

Heart alert: Taking more than directed can cause serious heart problems or death

Do not use

• if you have bloody or black stool
• in children under 12 years of age

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

• store at 20o-25o C (68o-77o F). Protect from light.
• avoid excessive heat above 40°C (104°F).
• do not use if carton or blister unit is open or torn
• see side panel for lot number and expiration date

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 1-877-753-3935- Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Imodium® A-D†

ANTI-DIARRHEAL

2 mg Loperamide HCI

CONTROL SYMPTOMS OF DIARRHEA

SUITABLE FOR ADULTS AND CHILDREN

12 YEARS AND OVER

SOFTGELS**

**each liquid-filled capsule contains 2 mg Loperamide HCl.

†This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Imodium® A-D.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785 1-877-846-9949

Product Label

CAREONE Anti-Diarrheal

INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL 
loperamide hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-520
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	10mm
Flavor		Imprint Code	P13
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-520-12	1 in 1 CARTON	08/05/2010
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	08/05/2010

Labeler - Care One (American Sales Company) (809183973)

Registrant - P & L Development, LLC (079765031)