Loperamide HCl and Simethicone

FDA Drug Profile — Loperamide HCl and Simethicone

Drug Details

Generic Name
Loperamide HCl and Simethicone
Brand Names
Loperamide HCl and Simethicone
Application Number
ANDA077500
Sponsor
Ohm Laboratories Inc.
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
DIMETHICONE, LOPERAMIDE HYDROCHLORIDE

Indications and Usage

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

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 • if you have difficulty swallowing Ask a doctor before use if you have • fever • mucus in the stool • a history of liver disease • a history of abnormal heart rhythm Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs. 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. • you have difficulty swallowing the caplet 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 (1800-222-1222).