Tums Chewy Bites With Gas Relief Tablet, Chewable
FDA Label NDC 0135-0624

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 Tums Chewy Bites With Gas Relief (NDC 0135-0624). 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 (per tablet), purpose, uses, ask a doctor or pharmacist before use if you are, when using this product, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per Tablet)

Calcium Carbonate USP 750 mg

Simethicone USP 80 mg

Purpose

Antacid

Antigas

Uses

relieves

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

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

Directions

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

Other Information

  • each chewable tablet contains: elemental calcium 300 mg
  • do not store above 25°C (77°F)

Inactive Ingredients

alcohol, ammonium hydroxide, beeswax, caprylic/capric triglycerides, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethanol, ethyl acetate, ethyl alcohol, FD&C blue #1 alum lake, FD&C red #40, FD&C red #40 alum lake, FD&C yellow #5 alum lake (tartrazine), FD&C yellow #6 alum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, modified corn starch, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, PVP, shellac, sodium benzoate, sorbic acid, sorbitol, soy bean oil, soy lecithin, sucrose, TBHQ, titanium dioxide

Questions Or Comments?

Call toll-free 1-800-897-7535

Principal Display Panel

NEW

NDC 0135-0624-01

TUMS® with Gas Relief

CALCIUM CARBONATE / SIMETHICONE

ANTACID/ANTIGAS

Chewy Bites

Lemon & Strawberry

FAST RELIEF OF HEARTBURN & GAS

28 CHEWABLE TABLETS

Safety sealed – Do not use if printed inner seal beneath cap is missing or broken.

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

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

©2016 GSK or its licensor

106111XA

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