FDA Label for Tums Smoothies

View Indications, Usage & Precautions

Tums Smoothies 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


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
  • •do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other Information



  • each tablet contains: elemental calcium 300mg
  • •store below 25oC (77oF). Keep the container tightly closed.

Inactive Ingredients (Assorted Fruit)



adipic acid, corn starch, dextrose, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, guar gum, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Contains: soy


Inactive Ingredients (Berry Fusion)



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

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?



1-800-897-7535 weekdays


Principal Display Panel



NDC 0135-0246-02

TUMS®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Assorted Fruit

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60 CHEWABLE TABLETS

PAREVE

©2014 GSK

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

GlaxoSmithKline

Moon Twp, PA 15108

Gluten-Free

www.tums.com

Front Panel 103644XA

Back Panel 103553XA

NDC 0135-0456-03

TUMS®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Berry Fusion

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60 CHEWABLE TABLETS

PAREVE

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

GSK CH

Warren, NJ 07059

Gluten-Free

©2014 GSK

Front Panel 103680XA

Back Panel 103725XA

NDC 0135-0245-02

TUMS®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Tropical Fruit

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60 CHEWABLE TABLETS

PAREVE

©2014 GSK

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

GlaxoSmithKline

Moon Twp, PA 15108

Gluten-Free

www.tums.com

Front Panel 103818XA

Back Panel 103816XA

NDC 0135-0243-02

TUMS®

CALCIUM CARBONATE

ANTACID

SmoothiesTM

Peppermint

SMOOTH DISSOLVE

EXTRA STRENGTH 750

GOES TO WORK IN SECONDS!

60 CHEWABLE TABLETS

PAREVE

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.

GSK Consumer Healthcare

Warren, NJ 07059

Gluten-Free

©2015 GSK or its licensor.

Front Panel 103728XB

Back Panel 103727XB


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