FDA Label for Simethicone
View Indications, Usage & Precautions
Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product Innovida Pharmaeutique Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Simethicone 125 mg
Purpose
Anti-gas
Uses
Relieves:
- pressure
- bloating
- symptoms referred to as gas
Warnings
KEEP OUT OF REACH OF CHILDREN. In case of an overdose, get medical help or contact a Poison Control Center immediately
Directions
- chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
- do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician
Other Information
- do not use if inner seal is broken
- store at room temperature
- avoid high humidity and excessive heat, above 40°C (104° F)
Inactive Ingredients
compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.
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Product Label
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