Active Ingredient (In Each Chewable Tablet)
Simethicone 125 mg
Gas Relief Tablet, Chewable
FDA Label NDC 80136-859
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Heartland Pharma Co. for the product Gas Relief (NDC 80136-859). 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 chewable tablet), purpose, uses, directions, other information, inactive ingredients, questions or comments?, principal display panel, 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
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
Heartland Pharma 44-608 (Heartland Pharma 44 608 1)
* Please review the disclaimer below.
