ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled 
QUALITY CHOICE (Chain Drug Marketing Association)

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Drug Facts

Active ingredient (in each capsule)

Loperamide HCI 2 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers' 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 a 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-25ºC (68º-77ºF)
  • 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 the active ingredient in Imodium® A-D

Anti-Diarrheal

Controls The Symptoms Of Diarrhea

Loperamide HCl, 2 mg

Suitable for adults and children 12 years and over

*Each Liquid-filled Capsule Contains 2 mg Loperamide HCl

Softgels*

©Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

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.

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

Product Label

Loperamide HCl 2 mg

Quality Choice Anti-Diarrheal Softgel

ANTI-DIARRHEAL 
loperamide hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63868-748
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
GLYCERYL CAPRYLATE 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
WATER 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize10mm
FlavorImprint Code P13
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-748-121 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02185505/31/2013
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 5/2013
Document Id: 89570c09-e0ff-4a01-a629-e34a3e5a5baa
Set id: a8681492-2480-409a-8fe2-df336baf7ce3
Version: 1
Effective Time: 20130528
 
QUALITY CHOICE (Chain Drug Marketing Association)