Anti-Diarrheal
Loperamide HCl Capsules - Quality Choice
35aa2daf-3486-7ee2-e063-6394a90ad473
HUMAN OTC DRUG LABEL
May 21, 2025
CHAIN DRUG MARKETING ASSOCIATION INC.
DUNS: 011920774
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LOPERAMIDE HYDROCHLORIDE
PRODUCT DETAILS
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
QC**®**
QUALITY CHOICE
NDC 83324-209-24
*Compare to the
Active Ingredient in
Imodium®A-D
Anti-Diarrheal
Loperamide HCl Soft Gelatin Capsules, 2 mg
Controls the Symptoms of Diarrhea
Suitable for Adults and Children
12 Years and Over
**†**Each Liquid-Filled Capsule Contains 2 mg Loperamide HCl
24 Softgels**†**
INDICATIONS & USAGE SECTION
Use
controls symptoms of diarrhea, including Travelers' Diarrhea
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each capsule)
Loperamide HCl 2 mg
OTC - PURPOSE SECTION
Purpose
Anti-diarrheal
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 and over: 2 capsules after the first loose stool; 1 capsule after each subsequent loose stool; but no more than 4 capsules in 24 hours
OTHER SAFETY INFORMATION
Other information
- store at 20°-25°C (68°-77°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 INGREDIENT SECTION
Inactive ingredients
butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water
OTC - QUESTIONS SECTION
Questions or comments?
call toll free1-888-235-2466
SPL UNCLASSIFIED SECTION
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.
*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium ® A-D
L0000929
Lot #
Expiration Date
R1024
Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
WARNINGS SECTION
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
OTC - DO NOT USE SECTION
Do not use
- if you have bloody or black stool
- in children under 12 years of age
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- fever
- mucus in the stool
- a history of liver disease
- a history of abnormal heart rhythm
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
taking a prescription drug. Loperamide may interact with certain prescription drugs.
OTC - WHEN USING SECTION
When using this product
tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,
ask a health professional before use.