loperamide hydrochloride

FDA Drug Profile — Loperamide Hydrochloride, anti-diarrheal

Drug Details

Generic Name
loperamide hydrochloride
Brand Names
Loperamide Hydrochloride, anti-diarrheal
Application Number
ANDA215579
Sponsor
Bryant Ranch Prepack
NDC Codes
11
Dosage Forms
CAPSULE, SOLUTION
Routes
ORAL
Active Ingredients
LOPERAMIDE HYDROCHLORIDE

Indications and Usage

Use controls symptoms of diarrhea, including Travelers' Diarrhea Read complete directions and warnings before using.

Warnings

Warnings Allergy alert Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Heart alert Taking more than directed can cause serious heart problems or death 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 symptoms get worse diarrhea lasts for more than 2 days 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)