LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE AUROHEALTH LLC FDA Approved Use controls symptoms of diarrhea, including Travelers' Diarrhea

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) Loperamide Hydrochloride USP 2 mg
Inactive Ingredients
Inactive ingredients butylated hydroxyanisole gelatin glycerin glyceryl monocaprylate neelicert FD&C Blue No.1 polyoxyl 40 hydrogenated castor oil purified water
Strengths
2 mg
Treats Conditions
Use Controls Symptoms Of Diarrhea Including Travelers Diarrhea
Pill Appearance
Shape: oval Color: blue Imprint: LO2

Identifiers & Packaging

Container Type BOX
UNII
77TI35393C
Packaging

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

Package Descriptions
  • 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

Overview

Use controls symptoms of diarrhea, including Travelers' Diarrhea

Indications & Usage

Use controls symptoms of diarrhea, including Travelers' Diarrhea

Dosage & Administration

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

Warnings & Precautions
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
Purpose

Purpose Anti-diarrheal

Do Not Use

Do not use if you have bloody or black stool in children under 12 years of age

When Using

When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop Use & Ask a Doctor

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.

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).

Questions

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


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