Tums Tablet
FDA Label NDC 0135-0071

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 0135-0071). 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 (assorted fruit), 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 500 mg

Purpose

Antacid

Uses

relieves

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Antacids may interact with certain prescription drugs.

When Using This Product

  • do not take more than 15 tablets in 24 hours
  • if pregnant do not take more than 10 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 2-4 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 tablet contains: elemental calcium 200mg
  • store below 30oC (86oF)

Inactive Ingredients (Assorted Fruit)

Adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

Inactive Ingredient (Peppermint)

corn starch, flavor, mineral oil, sodium polyphosphate, sucrose, talc

Questions?

1-800-897-7535

weekdays

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

Gluten-Free

www.tums.com

GlaxoSmithKline

Moon Twp, PA 15108

Principal Display Panel

NDC 0135-0071-27

TUMS®

CALCIUM CARBONATE

ANTACID

REGULAR STRENGTH 500

Goes to Work in Seconds!

Assorted Fruit

150 CHEWABLE TABLETS

PAREVE

©2014 GSK

Front Label: 103784XA

Back Label: 103783XA

NDC 0135-0070-27

TUMS®

CALCIUM CARBONATE

ANTACID

REGULAR STRENGTH 500

Goes to Work in Seconds!

Peppermint

150 CHEWABLE TABLETS

PAREVE

©2014 GSK

Front Label: 103781XA

Back Label: 103780XA

* Please review the disclaimer below.