Active Ingredient (In Each Capsule)
Loperamide HCl 2 mg
Anti-diarrheal Capsule, Liquid Filled
FDA Label NDC 72288-313
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amazon.com Services Llc for the product Anti-diarrheal (NDC 72288-313). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
- a history of abnormal heart rhythm
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug. Loperamide may interact with certain prescription drugs.
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 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 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 Ingredients
butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water
Questions Or Comments?
call toll free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)
Other
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 distrbuted by the owners of Imodium ®A-D
DISTRIBUTED BY:
AMAZON.COM SERVICES LLC
410 TERRY AVENUE N.
SEATTLE, WA 98109
© 2024 AMAZON.COM, INC. OR ITS
AFFILIATES. ALL RIGHTS RESERVED.
P-03928
R0623
L0000732
Lot #
Expiration Date
Carton
amazon
basic care
Anti-Diarrheal
NDC 72288-313-12
Compare to
Imodium ®A-D*
active ingredient
Loperamide
Hydrochloride
Capsules, 2 mg
Anti-Diarrheal
Controls the symptoms of diarrhea
Suitable for Adults and Children
12 Years and Over
24 Softgels**
**soft gelatin liquid-filled capsules
each softgel contains 2 mg loperamide HCl
Image001 (Image001)
* Please review the disclaimer below.
