Active Ingredient (In Each Tablet)
Simethicone 80 mg
Gas Relief Tablet, Chewable
FDA Label NDC 68163-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Gas Relief (NDC 68163-111). 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, directions, other information, inactive ingredients, 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
Relieves:
- bloating
- pressure
- symptoms referred to as gas
Directions
- thoroughly chew 1 to 2 tablets as needed after meals and at bedtime
- do not exceed 4 tablets in 24 hours period except under the advice and supervision of a physician.
Other Information
- store at room temperature 20-25°C (68-77°F)
- each tablets contains: calcium 60mg
Inactive Ingredients
dextrose, peppermint flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, tribasic calcium phosphate
Principal Display Panel
NDC 68163-111-36
Gas Relief
Anti Gas/Simethicone 80 mg
For fast relief of Bloating, Pressure & Gas Distress
Mint Flavor
Naturally and Artificially Flavored
36 CHEWABLE TABLETS
Manufactured by: Raritan Pharmaceuticals
8 Joanna Court, East Brunswick, NJ 08816
Drxchoice Gs Relief Simethicone 80mg (Leader 44 137 1)
* Please review the disclaimer below.
