Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 6d7be7e4-4bff-4cfd-bbbe-df412ac9db10
Route
ORAL
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (750 mg) Dimethicone (80 mg)
Inactive Ingredients
Alcohol Ammonia Yellow Wax Carnauba Wax Citric Acid Monohydrate Coconut Oil Starch, Corn Corn Syrup Icodextrin Ethyl Acetate Fd&c Blue No. 1 Aluminum Lake Fd&c Red No. 40 Aluminum Oxide Fd&c Yellow No. 5 Aluminum Lake Fd&c Yellow No. 6 Acacia Isopropyl Alcohol Maltodextrin Medium-chain Triglycerides Methylparaben Modified Corn Starch (1-octenyl Succinic Anhydride) Butyl Alcohol Phosphoric Acid Propylene Glycol Propylparaben Water Shellac Sodium Benzoate Sorbic Acid Sorbitol Soybean Oil Soybean Lecithin Sucrose Tert-butylhydroquinone Titanium Dioxide Corn Oil

Identifiers & Packaging

Pill Appearance
Imprint: T Shape: round Color: red Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-01

Description

Calcium carbonate USP 750 mg Simethicone USP 80 mg

Purpose

Antacid Antigas


Medication Information

Purpose

Antacid Antigas

Description

Calcium carbonate USP 750 mg Simethicone USP 80 mg

Uses

relieves

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

Antacid

Antigas

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
Other Information
  • each chewable tablet contains: elemental calcium 300 mg
  • do not store above 25°C (77°F)
  • contains FD&C Yellow No.5 (tartrazine) as a color additive
Inactive Ingredients

alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, 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, medium-chain triglycerides, methylparaben, modified corn starch, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy bean oil, soy lecithin, sucrose, tert-butylhydroquinone, titanium dioxide, vegetable oil

Additional Information

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

Questions Or Comments?

Call toll-free 1-800-897-7535

Principal Display Panel

NEW LOOK

HALEON

FAST RELIEF OF HEARTBURN & GAS

CALCIUM CARBONATE / SIMETHICONE

TUMS with Gas Relief

ANTACID/ANTIGAS

Chewy Bites

Relieves:

  • Heartburn
  • Acid Indigestion
  • Upset Stomach
  • Bloating and Gas

Lemon & Strawberry

54 CHEWABLE TABLETS

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
Active Ingredients (per Tablet)

Calcium carbonate USP 750 mg

Simethicone USP 80 mg

Ask A Doctor Or Pharmacist Before Use If You Are

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


Structured Label Content

Uses

relieves

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

Antacid

Antigas

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
Other Information (Other information)
  • each chewable tablet contains: elemental calcium 300 mg
  • do not store above 25°C (77°F)
  • contains FD&C Yellow No.5 (tartrazine) as a color additive
Inactive Ingredients (Inactive ingredients)

alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, 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, medium-chain triglycerides, methylparaben, modified corn starch, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy bean oil, soy lecithin, sucrose, tert-butylhydroquinone, titanium dioxide, vegetable oil

Additional Information

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

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-897-7535

Principal Display Panel

NEW LOOK

HALEON

FAST RELIEF OF HEARTBURN & GAS

CALCIUM CARBONATE / SIMETHICONE

TUMS with Gas Relief

ANTACID/ANTIGAS

Chewy Bites

Relieves:

  • Heartburn
  • Acid Indigestion
  • Upset Stomach
  • Bloating and Gas

Lemon & Strawberry

54 CHEWABLE TABLETS

When Using This Product (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
Active Ingredients (per Tablet) (Active ingredients (per tablet))

Calcium carbonate USP 750 mg

Simethicone USP 80 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

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


Advanced Ingredient Data


Raw Label Data

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