ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled 
Care One (American Sales Company)

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Loperamide HCl 2 mg

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

Do not use

Ask a doctor before use if you have

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

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

Other information

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 IN IMODIUM® A-D **

Anti-Diarrheal

Soft Gelatin Capsules, 2 mg

Loperamide HCl

Controls the symptoms of diarrhea

Suitable for adults and children 12 years and over

LIQUID- FILLED 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.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: American Sales Company

4201 walden ave, Lancaster, NY 14086

Manufactured by: Banner Pharmacaps Inc.

4125 Premier drive, High point, NC 27265

Product Label

CareOne

Loperamide HCl 2 mg

ANTI-DIARRHEAL 
loperamide hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-520(NDC:10888-7098)
Route of Administration ORAL DEA Schedule     
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 CAPRYLATE (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
1 12 in 1 BLISTER PACK
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 and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: 4a528336-6dd8-445a-aaf3-2f87c1199059
Set id: 057c724e-f03e-4120-8cd1-ae58104e1c21
Version: 1
Effective Time: 20121227
 
Care One (American Sales Company)