Active Ingredient
Simethicone 125 mg
The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Gas-x (NDC 0067-0129). 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, purpose, uses, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Simethicone 125 mg
Antigas
for the relief of
• pressure, bloating, and fullness commonly referred to as gas
• adults: chew 1 or 2 tablets as needed after meals and at bedtime
• do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician
• each tablet contains: calcium 45 mg
• store at controlled room temperature 20-25°C (68-77°F)
• protect from moisture
calcium phosphate tribasic, colloidal silicon dioxide, D&C Red 30
aluminum lake, D&C Yellow 10 aluminum lake, dextrose, flavors, maltodextrin, starch
call 1-800-452-0051
www.gas-x.com
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