Extra Strength Gas Relief Tablet, Chewable
FDA Label NDC 21130-110

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Extra Strength Gas Relief (NDC 21130-110). 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 for relief of, 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

Anti-gas

Uses For Relief Of

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

Directions

  • ▪adults: chew 1 to 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
  • store at room temperature
  • protect from excessive heat and moisture

Inactive Ingredients

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

Questions Or Comments?

1-866-467-2748

Principal Display Panel

  •  *Compare to the active ingredient in Gas-X® Extra Strength

    • Extra Strength

    Gas Relief

    Simethicone /Antigas

    For Fast Relief of Pressure, Bloating & Discomfort

    Cherry Creme Flavor

    Natural and Artificially Flavored

    18 CHEWABLE TABLETS

    DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN

    *This product is not manufactured or distributed by GSK Consumer Healthcare Inc., the distributor of GAS-X® Extra Strength.

    Distributed by:

    IMPORTANT: Keep this carton for future reference on full labeling.

    Package Label for 18 Chewable Tablets

    Extra Strength Gas Relief Simethicone 18 Chewable Tablets (Wc134chr)

    Extra Strength Gas Relief Simethicone 18 Chewable Tablets (Wc134chr)

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