Topcare Extra Strength Gas Relief Tablet, Chewable
FDA Label NDC 36800-488

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Extra Strength Gas Relief (NDC 36800-488). 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, 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

Foe the 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 hour except under the advice and supervision of a physician

Other Information

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

Inactive Ingredients

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

Questions Or Comments?

1-866-467-2748

Principal Display Panel

NDC 36800-488-48

Compare to the active ingredientGas-X® Extra Strength

Extra Strength

Gas Relief

Simethicone 125 mg/ Antigas

  •  For Fast Relief of Pressure, Bloating & Discomfort

    • Cherry Creme Flavor

    Naturally and Artificially Flavored

    48 CHEWABLE TABLETS

    DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

    DISTRIBUTED BY: TOPCO ASSOCIATES LLC,

    ELK GROVE VILLAGE, IL 60007

    © TOPCO RARA1217

    QUESTIONS? 1-888-423-0139

    [email protected], www.topcarebrand.com

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

    Topcare Extra Strength Simethicone 48 Chewable Tablets (Wc134chr)

    Topcare Extra Strength Simethicone 48 Chewable Tablets (Wc134chr)

* Please review the disclaimer below.