Indications
Use controls symptoms of diarrhea, including Travelers' Diarrhea
Warnings and precautions
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 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. 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)
Pregnancy and breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Composition
- Active ingredients
- LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- LOPERAMIDE HYDROCHLORIDE 2MG · TabletNDA019860-001 · Over the counter
- LOPERAMIDE HYDROCHLORIDE 1MG/5ML · SolutionNDA019487-001 · Discontinued
- LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML · SolutionThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA019487.
At a glance
- Brand name
- Imodium A-D
- Active substance
- loperamide hydrochloride
- Route
- Oral
- Dosage form
- Solution
- Applicant
- Kenvue Brands
- Status
- Over the counter
- FDA approval
- 1 Mar 1988
- Application
- NDA019487-002