Tums Tablet, Chewable
FDA Label NDC 0135-0221

21 label sections · Submitted to the FDA by Haleon Us Holdings Llc · 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 0135-0221). 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, other information (mixed berry), 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 750 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

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

When Using This Product

  • do not take more than 10 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 2 – 4 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 300 mg
  • store below 25 oC (77 oF). Keep the container tightly closed.

Other Information (Mixed Berry)

  • each tablet contains:elemental calcium 300 mg
  • do not store above 25 oC (77 oF). Keep the container tightly closed.

Other Information(Assorted Fruit)

  • each tablet contains:elemental calcium 300 mg
  • store below 25 oC (77 oF). Keep the container tightly closed.
  • contains FD&C Yellow No. 5 (tartrazine) as a color additive

Inactive Ingredients (Assorted Fruit)

acacia, adipic acid, calcium stearate, dextrose, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, flavors, guar gum, microcrystalline cellulose, sorbitol

Contains: soy

Inactive Ingredients (Berry Fusion) (Mixed Berry)

acacia, adipic acid, calcium stearate, dextrose, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, guar gum, microcrystalline cellulose, sorbitol

Contains: soy

Inactive Ingredient (Assorted Tropical Fruit)

adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Contains: soy

Inactive Ingredients (Peppermint)

corn starch, dextrose, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Questions Or Comments?

1-800-897-7535

Questions? (Mixed Berry)

1-800-452-0051

Generic Section (Assorted Fruit, Berry Fusion, Mixed Berry)

Do not use if printed inner safety seal under cap is broken or missing.

Gluten-Free

Principal Display Panel (Assorted Fruit)

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Smoothies

Assorted Fruit

SMOOTH DISSOLVE

140 CHEWABLE TABLETS

EXTRA STRENGTH 750

PARVE

Principal Display Panel (Berry Fusion)

GOES TO WORK IN SECONDS!

CALCIUM CARBONATE

TUMS

ANTACID

Smoothies

Berry Fusion

SMOOTH DISSOLVE

140 CHEWABLE TABLETS

EXTRA STRENGTH 750

PARVE

Principal Display Panel (Tropical Fruit)

NDC 0135-0245-02

TUMS ®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Tropical Fruit

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60CHEWABLE TABLETS

PAREVE

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

Tums Smoothies Tropical Fruit 60 Count Front Label (58afb9fd C44a 41a8 Aa2f F535e6258539 03)

Tums Smoothies Tropical Fruit 60 Count Front Label (58afb9fd C44a 41a8 Aa2f F535e6258539 03)

Principal Display Panel (Peppermint)

NDC 0135-0243-02

TUMS ®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Peppermint

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60CHEWABLE TABLETS

PAREVE

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

Tums Smoothies Peppermint 60 Count Front Label (58afb9fd C44a 41a8 Aa2f F535e6258539 04)

Tums Smoothies Peppermint 60 Count Front Label (58afb9fd C44a 41a8 Aa2f F535e6258539 04)

Principal Display Panel (Mixed Berry)

CALCIUM CARBONATE

TUMS

ANTACID

GOES TO WORK IN SECONDS!

Smoothies

Mixed Berry

SMOOTH DISSOLVE

236 CHEWABLE TABLETS

EXTRA STRENGTH 750

PARVE

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