FDA Label for Gas Relief
View Indications, Usage & Precautions
Gas Relief Product Label
The following document was submitted to the FDA by the labeler of this product Northeast Pharma. 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 Chewable Tablet)
Simethicone 125 mg
Purpose
Antigas
Uses
for the relief of pressure, bloating, and fullness commonly referred to as gas
Directions
- do not take more than directed
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime
- do not exceed 4 chewable tablets in 24 hours unless directed by a doctor
- children under 12 years: ask a doctor
Other Information
- each tablet contains: calcium 85 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
- use by expiration date on package
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 Or Comments?
1-800-383-0648
Principal Display Panel
Heartland®
Pharma Co.
NDC 80136-859-68
Extra Strength
GAS RELIEF
Simethicone 125 mg Chewable Tablets
Antigas
Relieves
Pressure
Bloating
Discomfort
Compare to the
active ingredient in
Gas-X® Extra Strength*
Chew or crush tablets completely before swallowing.
100 Chewable Tablets
Actual
Size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by GSK Consumer
Healthcare S.A., owner of the registered trademark Gas-X® Extra Strength.
50844 ORG122060812
Distributed by:
NORTHEAST PHARMA
Williston, VT 05495
www.heartlandpharmaco.com
1-800-383-0648
* Please review the disclaimer below.