Tums Chewy Bites with Gas Relief

CALCIUM CARBONATE AND SIMETHICONE ORAL HUMAN OTC DRUG

Tums Chewy Bites with Gas Relief is an FDA drug label for the active ingredient CALCIUM CARBONATE AND SIMETHICONE manufactured by Haleon US Holdings LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260609.

Generic name
CALCIUM CARBONATE AND SIMETHICONE
Manufacturer
Haleon US Holdings LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
0135-0624
Application
M001
Label effective
20260609

About this product

Tums Chewy Bites with Gas Relief is an FDA-registered drug product whose active ingredient is CALCIUM CARBONATE AND SIMETHICONE. It is labelled by Haleon US Holdings LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0135-0624, application M001, label effective 20260609. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing CALCIUM CARBONATE AND SIMETHICONE are most often described in connection with: acid indigestion, sour stomach, relieves heartburn, symptoms gas. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (per tablet) Calcium carbonate USP 750 mg Simethicone USP 80 mg

Indications & Usage

Uses relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms gas associated with heartburn, sour stomach, or acid indigestion

Dosage & Administration

Directions adults and children 12 years of age and over: chew 1-2 tablets as symptoms occur, or as directed by a doctor. Chew or crush tablets completely before swallowing. do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Warnings

Warnings Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 6 tablets in 24 hours if pregnant do not take more than 6 tablets in 24 hours do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor Keep out of reach of children.

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-0595-2026 Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059. Haleon US Holdings LLC Class I Ongoing 20260617
D-0542-2026 Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9. Haleon US Holdings LLC Class II Ongoing 20260527
D-0297-2026 parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02 Haleon US Holdings LLC Class III Ongoing 20260204
D-0592-2025 Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2 Haleon US Holdings LLC Class III Ongoing 20250827
D-0317-2024 Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059 Haleon US Holdings LLC Class I Terminated 20240131

Frequently asked questions

What is Tums Chewy Bites with Gas Relief used for?
Uses relieves heartburn acid indigestion sour stomach upset stomach associated with these symptoms gas associated with heartburn, sour stomach, or acid indigestion

Who makes Tums Chewy Bites with Gas Relief?
Haleon US Holdings LLC is the labeler of record for Tums Chewy Bites with Gas Relief.

What form does Tums Chewy Bites with Gas Relief come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Tums Chewy Bites with Gas Relief prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Tums Chewy Bites with Gas Relief been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.