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LOPERAMIDE HYDROCHLORIDE

Dosage form
CAPSULE, LIQUID FILLED
Labeler
Aurohealth LLC
Label updated
2026-01-05
Retrieved
2026-09-07
Active ingredients
LOPERAMIDE HYDROCHLORIDE
View original label and images on DailyMed ↗
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