FDA Label for Tums Chewy Bites With Gas Relief

View Indications, Usage & Precautions

Tums Chewy Bites With Gas Relief Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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