loperamide hydrochloride and dimethicone

FDA Drug Profile — IMODIUM Multi-Symptom Relief

Drug Details

Generic Name
loperamide hydrochloride and dimethicone
Brand Names
IMODIUM Multi-Symptom Relief
Application Number
NDA021140
Sponsor
Kenvue Brands LLC
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. (1-800-222-1222)