Active Ingredient (In Each Tablet)
Simethicone 80 mg
Simethicone Tablet, Chewable
FDA Label NDC 57896-791
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceuticals, Corp for the product Simethicone (NDC 57896-791). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
