Simethicone
SIMETHICONE
ORAL
HUMAN OTC DRUG
Simethicone is an FDA drug label for the active ingredient SIMETHICONE manufactured by Advance Pharmaceutical Inc. 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 20181217.
- Generic name
- SIMETHICONE
- Manufacturer
- Advance Pharmaceutical Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 17714-040
- Application
- part332
- Label effective
- 20181217
Active ingredients
Active Ingredient (in each chewable tablet) Simethicone 125 mg
Indications & Usage
Uses relieves bloating pressure discomfort of gas which can be caused by certain foods or air swallowing
Dosage & Administration
Directions chew thoroughly 1 to 2 tablets as needed after meals and at bed time. do not exceed 6 tablets per day unless directed by a physician
Contraindications
Not available.
Warnings
Warnings If pregnant or breast-feeding, ask a health professional before use.
Adverse Reactions
Not available.