Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE PREFERRED PHARMACEUTICALS INC. FDA Approved Use controls symptoms of diarrhea, including Travelers' Diarrhea
FunFoxMeds box
Route
ORAL
Applications
ANDA206548
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient (in each tablet) Loperamide hydrochloride USP 2 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide D & C yellow No. 10 aluminum lake FD & C blue No. 1 lactose monohydrate magnesium stearate microcrystalline cellulose and sodium starch glycolate
Strengths
2 mg
Quantities
24 tablets
Treats Conditions
Use Controls Symptoms Of Diarrhea Including Travelers Diarrhea
Pill Appearance
Shape: capsule Color: green Imprint: L;28

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
77TI35393C
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets) AUROHEALTH Relabeled By: Preferred Pharmaceuticals Inc. NDC 68788-8393 *Compare to the active ingredient of Imodium ® A-D Loperamide Hydrochloride Tablets USP 2 mg Anti-Diarrheal Controls the symptoms of diarrhea 24 Tablets Loperamide HCL Tablets USP 2mg

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets) AUROHEALTH Relabeled By: Preferred Pharmaceuticals Inc. NDC 68788-8393 *Compare to the active ingredient of Imodium ® A-D Loperamide Hydrochloride Tablets USP 2 mg Anti-Diarrheal Controls the symptoms of diarrhea 24 Tablets Loperamide HCL Tablets USP 2mg

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 • find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9 to 11 years (60 to 95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6 to 8 years (48 to 59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours children 2 to 5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

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

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 (1-800-222-1222) right away.

Storage & Handling

Other information • store at 20° to 25°C (68° to 77°F). • do not use if carton or blister unit is open or torn • Meets USP dissolution test 2 • See side panel for lot number and expiration date

Questions

Questions or comments? call 1-855-274-4122 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code .: TS/DRUGS/22/2009 Relabeled By: Preferred Pharmaceuticals Inc.


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