Extra Strength Gas Relief
FDA Label NDC 63868-854

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Extra Strength Gas Relief (NDC 63868-854). 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

→ Active Ingredient (in Each Tablet)

→ Purpose

→ Uses

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Active Ingredient (In Each Tablet)

Simethicone 125 mg

Purpose

Anti-gas

Uses

For the relief of

Pressure, bloating and fullness commonly referred to as gas

Directions

adults: chew 1 to 2 tablets completely as needed after meals and at bedtime. Do not swallow tablets whole.
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician.

Other Information

each tablets contains: calcium 45 mg
store at room temperature
protect from excessive heat and moisture

DO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN

Inactive Ingredients

D & C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate