LOPERAMIDE HYDROCHLORIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Labeler
- Aurohealth LLC
- Label updated
- 2026-01-05
- Retrieved
- 2026-09-07
- Active ingredients
- LOPERAMIDE HYDROCHLORIDE
Active ingredient (in each capsule)
Loperamide Hydrochloride USP, 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 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
Label information
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.
Label information
If pregnant or breast-feeding, ask a health professional before use.
Label information
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
[Image in the official label — see DailyMed source]
DailyMed Set ID: f9a53a23-a8ea-4521-8f0b-1bc2a658ff68 · Version 1
NDC: 58602-727