Active Ingredient (In Each Tablet)
Simethicone 125 mg
Extra Strength Simethicone Tablet, Chewable
FDA Label NDC 37835-233
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Extra Strength Simethicone (NDC 37835-233). 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, if pregnant or breast feeding,, 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
Uses
for the relief of pressure, bloating, and fullness commonly referred to as gas
If Pregnant Or Breast Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or a Poison Control Center (1-800-222-1222) right away.
Directions
- adults:chew one or two 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
Other Information
- each tablet contains:calcium 85 mg
- TAMPER EVIDENT:DO NOT USE IF SEAL AROUN TABLET IS BROKEN OR DAMAGED
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
Inactive Ingredients
crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate.
Questions?
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