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 Geri-care Pharmaceuticals, Corp. 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 80 mg
Purpose
Anti-Gas
Uses
for the relief of
- pressure, bloating, and fullness commonly referred to as gas
Warnings
When using this product • do not take more than directed, except under the advice of a doctor
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• adults and children 12 years and over, chew 1-2 tablets as needed after meals and at bedtime
• chew thoroughly
• do not exceed 6 tablets in 24 hours
• children under 12 years, consult a doctor
Other Information
- Tamper Evident: Do not use if imprinted seal under cap is missing or broken
- store at room temperature, 15°C - 30°C (59˚F - 86˚F)
Inactive Ingredients
dextrose, peppermint flavor, silica, sorbitol, stearic acid, talc, calcium phosphate.
Package Label
GERICARE
NDC 57896-791-01
CHEWABLE
SIMETHICONE
TABLETS USP, 80mg
FOR GAS DISTRESS
MINT FLAVOR
100 Tablets
80 mg each
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