Active Ingredient (In Each Capsule)
Loperamide Hydrochloride USP, 2 mg
Loperamide Hydrochloride Capsule, Liquid Filled
FDA Label NDC 58602-727
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Loperamide Hydrochloride (NDC 58602-727). 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, otc - ask doctor/pharmacist, 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 hydrochloride
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
Otc - Ask Doctor/Pharmacist
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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° to 25°C (68° to 77°F) [See USP controlled room temperature]. Protect from light.
- do not use if carton or blister unit is open or torn
- avoid excessive heat above 40°C (104°F)
- see side panel for lot number and expiration date
- FDA approved dissolution test specifications differ from USP.
Inactive Ingredients
butylated hydroxyanisole, gelatin, glycerin, glyceryl monocaprylate, neelicert FD&C Blue No.1, polyoxyl 40 hydrogenated castor oil, purified water
Questions Or Comments?
call toll free 1-855-274-4122
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/16/2014
Package Label-Principal Display Panel - 2 Mg (24 Softgels) Blister Carton Label
AUROHEALTH
NDC 58602-727-76
†Compare to the active ingredient
in Imodium® A-D
Loperamide Hydrochloride
Capsules USP, 2 mg
(Soft Gelatin Capsules)
Anti-Diarrheal
Controls the symptoms of diarrhea
Suitable for adults and children 12 years and over
Actual Size
24 Softgels*
*each liquid-filled capsule contains
2 mg Loperamide Hydrochloride, USP
Figure1 (Loperamide Fig1)
* Please review the disclaimer below.
