Drug Facts
f9a53a23-a8ea-4521-8f0b-1bc2a658ff68
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Loperamide Hydrochloride USP, 2 mg
Purpose
Anti-diarrheal
Medication Information
Purpose
Anti-diarrheal
Description
Loperamide Hydrochloride USP, 2 mg
Use
controls symptoms of diarrhea, including Travelers' Diarrhea
Section 50565-1
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).
Section 50568-5
Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
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
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
Do Not Use
- if you have bloody or black stool
- in children under 12 years of age
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
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.
Active Ingredient (in Each Capsule)
Loperamide Hydrochloride USP, 2 mg
Ask A Doctor Before Use If You Have
- fever
- mucus in the stool
- a history of liver disease
- a history of abnormal heart rhythm
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
Structured Label Content
Use
controls symptoms of diarrhea, including Travelers' Diarrhea
Section 50565-1 (50565-1)
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).
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purpose
Anti-diarrheal
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
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
Do Not Use (Do not use)
- if you have bloody or black stool
- in children under 12 years of age
Other Information (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 (Inactive ingredients)
butylated hydroxyanisole, gelatin, glycerin, glyceryl monocaprylate, neelicert FD&C Blue No.1, polyoxyl 40 hydrogenated castor oil, purified water
Questions Or Comments? (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
When Using This Product (When using this product)
tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.
Stop Use and Ask A Doctor If (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.
Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))
Loperamide Hydrochloride USP, 2 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
- fever
- mucus in the stool
- a history of liver disease
- a history of abnormal heart rhythm
Package Label Principal Display Panel 2 Mg (24 Softgels) Blister Carton Label (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
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:08:07.015001 · Updated: 2026-03-14T23:12:15.627416