Loperamide Hydrochloride, Simethicone
Loperamide Hydrochloride, Simethicone is an FDA drug label for the active ingredient LOPERAMIDE HYDROCHLORIDE, SIMETHICONE manufactured by Guardian Drug Company administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20210601.
- Generic name
- LOPERAMIDE HYDROCHLORIDE, SIMETHICONE
- Manufacturer
- Guardian Drug Company
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 53041-263
- Application
- ANDA214541
- Label effective
- 20210601
Active ingredients
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 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets 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
Contraindications
Not available.
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
Adverse Reactions
Not available.