FDA
Loperamide Hydrochloride
The FDA lists this product in 33 strengths and forms.
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.
At a glance
- Brand name
- Loperamide Hydrochloride
- Route
- Oral
- Dosage form
- Solution
- Applicant
- Bionpharma
- Status
- Over the counter
- FDA approval
- 19 Sept 2025
- Application
- ANDA220100-001