Loperamide Hydrochloride 1 mg/7.5mL
Loperamide Hydrochloride oral · SOLUTION · Bionpharma Inc.
Loperamide hydrochloride is an over-the-counter medication taken by mouth to treat diarrhea by slowing intestinal movement. It comes as an oral solution with a strength of 1 mg per 7.5 mL.
Key Facts
- Brand Name
- Loperamide Hydrochloride
- Generic Name
- Loperamide Hydrochloride oral
- NDC Code (Product)
69452-405- Manufacturer
- Bionpharma Inc.
- Strength
- 1 mg/7.5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA220100
- Marketing Start
- 03/02/2026
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
USE(S) relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Dosage & Administration
DIRECTIONS • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • take only on an empty stomach (1 hour before or 2 hours after a meal) • take with a full (8 oz.) glass of water • find right dose on chart below. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9-11 years (60-95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6-8 years (48-59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use
Warnings
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
Frequently Asked Questions
What is Loperamide Hydrochloride used for?
Loperamide hydrochloride is an over-the-counter medication taken by mouth to treat diarrhea by slowing intestinal movement. It comes as an oral solution with a strength of 1 mg per 7.5 mL.
Is Loperamide Hydrochloride a controlled substance?
Loperamide Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Loperamide Hydrochloride?
The generic name for Loperamide Hydrochloride is Loperamide Hydrochloride oral. There are no other listed brand versions of Loperamide Hydrochloride oral.
What is the NDC code for Loperamide Hydrochloride 1 mg/7.5mL?
The NDC (National Drug Code) for Loperamide Hydrochloride 1 mg/7.5mL is 69452-405, listed by Bionpharma Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)