FDA Label for Extra Strength Simethicone
View Indications, Usage & Precautions
Extra Strength Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product Bi-mart. 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 125 mg
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?
call toll free 1-844-912-4012
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