Active Ingredient (In Each Capsule)
Loperamide Hydrochloride USP, 2 mg
Loperamide Hydrochloride Capsule, Liquid Filled
FDA Label NDC 59556-959
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strides Pharma, Inc. for the product Loperamide Hydrochloride (NDC 59556-959). 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 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, FD&C Blue #1, gelatin, glycerol, glyceryl mono caprylo caprate, polyoxyl 40 hydrogenated castor oil, purified water,
printing ink white-edible oil – dewaxed bleached shellac resins, propylene glycol, sodium lauryl sulphate, titanium dioxide.
Questions Or Comments?
go to www.strides.com or call Strides Pharma Inc. weekdays from 9 AM to 5 PM EST at 1-877-244-9825
Manufactured by:
Strides Pharma Science Limited
Bengaluru-562106, India.
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
Issued: 06/2020
†All trademarks are property of their respective owners. This product is not affiliated with the makers/owners 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.
Package Label.Principal Display Panel
†COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ® A-D
NDC 59556-959-06
Loperamide Hydrochloride Capsules USP, 2 mg
Anti-Diarrheal
Suitable for adults and children 12 years and over
12 Softgels*
*each Liquid-filled capsule contains 2 mg Loperamide Hydrochloride, USP
Carton Label (Ae32cc2b 6d27 4997 B8e9 2ed3618b8684 01)
* Please review the disclaimer below.
