Active Ingredient (In Each Tablet)
Simethicone 125 mg
Extra Strength Gas Relief Tablet, Chewable
FDA Label NDC 57896-694
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 Extra Strength Gas Relief (NDC 57896-694). 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, use, 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
Antigas
Use
for the relief of pressure, bloating, and fullness commonly referred to as gas
Warnings
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
- chew thoroughly
- adults and children 12 years and over: take 1-2
- children under 12 years: ask a doctor
tablets as needed after meals and at bedtime. Do
not exceed 4 tablets in 24 hours except under the
advice and supervision of 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)
- protect from moisture
Inactive Ingredients
dextrose, sugar, maltodextrin, microcrystalline cellulose, peppermint flavor, silica, sorbitol, stearic acid
Questions Or Comments?
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Package Label
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