Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE PROFICIENT RX LP FDA Approved USE(S) controls symptoms of diarrhea, including Travelers’ Diarrhea
FunFoxMeds box
Route
ORAL
Applications
ANDA074091
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT (IN EACH CAPLET) Loperamide HCl USP 2 mg
Inactive Ingredients
INACTIVE INGREDIENTS anhydrous lactose croscarmellose sodium crospovidone D&C yellow no.10 FD&C blue no.1 hydrogenated vegetable oil magnesium stearate powdered cellulose pregelatinized starch
Strengths
2 mg
Treats Conditions
Use S Controls Symptoms Of Diarrhea Including Travelers Diarrhea
Pill Appearance
Shape: capsule Color: green Imprint: 123

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0363187462123
UNII
77TI35393C
Packaging

PRINCIPAL DISPLAY PANEL NDC 63187-462-12 Loperamide HCl Tablets, USP 2 mg Anti-Diarrheal 12 CAPLETS † Each caplet( † capsule-shaped tablet) contains Loperamide HCl, USP 2 mg Controls The Symptoms of Diarrhea * Compare to the active ingredient of Imodium ® A-D * This product is not manufactured or distributed by McNeil-PPC, distributor of Imodium ® A-D . Imodium ® is a registered trademark of Johnson & Johnson. 63187-462-12

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 63187-462-12 Loperamide HCl Tablets, USP 2 mg Anti-Diarrheal 12 CAPLETS † Each caplet( † capsule-shaped tablet) contains Loperamide HCl, USP 2 mg Controls The Symptoms of Diarrhea * Compare to the active ingredient of Imodium ® A-D * This product is not manufactured or distributed by McNeil-PPC, distributor of Imodium ® A-D . Imodium ® is a registered trademark of Johnson & Johnson. 63187-462-12

Overview

USE(S) controls symptoms of diarrhea, including Travelers’ Diarrhea

Indications & Usage

USE(S) 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 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children under 6 years (up to 47 lbs) ask a doctor

Warnings & Precautions
WARNINGS Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI Do not use if you have bloody or black stool Ask a doctor before use if you have • fever • mucus in the stool • a history of liver disease Ask a doctor or pharmacist before use if you are taking antibiotics When using this product • tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if • diarrhea lasts for more than 2 days • symptoms get worse • you get abdominal swelling or bulging. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. 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).
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 • diarrhea lasts for more than 2 days • symptoms get worse • 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).

Storage & Handling

OTHER INFORMATION • store between 20° – 25° C (68° – 77° F) • see side panel for lot number and expiration date • TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Questions

QUESTIONS? call 1800-406-7984 Keep the carton. It contains important information. Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320


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