Tums Tablet, Chewable
FDA Label NDC 0135-0553

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 (NDC 0135-0553). 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, warnings, 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 1000 mg

Purpose

Antacid

Uses

relieves

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms

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 7 tablets in 24 hours
  • if pregnant do not take more than 5 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 2-3 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

Other Information

  • each tablet contains: elemental calcium 400 mg, magnesium 10 mg
  • store below 30°C (86°F)
  • contains FD&C Yellow No. 5 (tartrazine) as a color additive

Inactive Ingredients

corn starch, crospovidone, dextrose, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavor, magnesium stearate, maltodextrin, sucrose, talc

Questions?

1-800-897-7535

Additional Information

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

Trademarks owned or licensed by GSK.
Dist. by: GSK CH
Warren, NJ 07059

©2022 GSK or licensor.

Gluten-Free

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CALCIUM CARBONATE
TUMS
ANTACID

Tropical
Fruit

72 CHEWABLE TABLETS

ULTRA
STRENGTH 1000

202113 Back Label
202112 Front Label

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