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.

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

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 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

Loperamide HCI 2 mg

CAREONE Anti-Diarrheal

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 (800014821)

Revised: 4/2017
Document Id: 878f02c8-0781-450f-b321-76f840060dbf
Set id: 057c724e-f03e-4120-8cd1-ae58104e1c21
Version: 3
Effective Time: 20170421
 
Care One (American Sales Company)