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 hydrochloride Heart alert: Taking more than directed can cause serious heart problems or death
Pregnancy and breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Composition
- Active ingredients
- LOPERAMIDE HYDROCHLORIDE 2MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- LOPERAMIDE HYDROCHLORIDE 2MG · TabletANDA076497-001 · Over the counter
- LOPERAMIDE HYDROCHLORIDE 2MG · CapsuleANDA072741-001 · Prescription
- LOPERAMIDE HYDROCHLORIDE 2MG · CapsuleANDA073122-001 · Discontinued
- LOPERAMIDE HYDROCHLORIDE 2MG · TabletANDA074194-001 · Discontinued
- LOPERAMIDE HYDROCHLORIDE 2MG · CapsuleANDA216876-001 · Prescription
- LOPERAMIDE HYDROCHLORIDE 1MG/5ML · SolutionANDA074730-001 · Discontinued
- LOPERAMIDE HYDROCHLORIDE 1MG/5ML · SolutionANDA074991-001 · Discontinued
- LOPERAMIDE HYDROCHLORIDE 2MG · CapsuleThis page
At a glance
- Brand name
- Loperamide Hydrochloride
- Route
- Oral
- Dosage form
- Capsule
- Applicant
- Aurobindo Pharma
- Status
- Over the counter
- FDA approval
- 29 Dec 2025
- Application
- ANDA220372-001



