Gas-x Tablet, Chewable
FDA Label NDC 0067-0117

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Gas-x (NDC 0067-0117). 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, use, 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

Active Ingredient (In Each Tablet)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of

• pressure, bloating, and fullness commonly referred to as gas

Directions

• adults: chew 1 or 2 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 45 mg

• store at controlled room temperature 20-25°C (68-77°F)

• protect from moisture

Inactive Ingredients

calcium phosphate tribasic, colloidal silicon dioxide, D&C Red 30 aluminum lake, dextrose, flavors, maltodextrin, propylene glycol, soy protein isolate

Questions Or Comments?

call 4

Principal Display Panel

NDC 0067-0117-48

Gas-X®

SIMETHICONE 125 mg /ANTIGAS

RELIEVES GAS FAST

Pressure • Bloating • Discomfort

EXTRA STRENGTH

CHERRY CREME

48 Chewable Tablets

Gas-X® Extra Strength Cherry Creme chewable tablets have a pleasantly smooth, creamy cherry flavor. Chewable tablets are also available in a great tasting Peppermint Crème flavor.

TAMPER EVIDENT FEATURE:

Gas-X® tablets are sealed in blister packets. Use only if the individual seal is unbroken.

Gas-X®Extra Strength Tablets offer fast, effective relief of pressure and bloating that antacids can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating or discomfort referred to as gas.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2016 GSK group of companies or its licensor. All rights reserved.

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