Tums freshers

Dosage form: tablet, chewable
Ingredients: CALCIUM CARBONATE 500mg
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0522

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (per tablet)

Calcium carbonate USP 500mg

Purpose

Antacid

Uses

relieves

heartburn
sour stomach
acid indigestion
upset stomach associated with these symptoms

Warnings

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 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

Keep Out of Reach of Children.

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 25°C (77°F)

Inactive ingredients (Cool Mint)

calcium stearate, corn starch, FD&C Blue #1, flavors, gum acacia, maltodextrin, sorbitol, sucralose, sucrose, tocopherols

Inactive ingredients (Spearmint)

calcium stearate, corn starch, FD&C Yellow #5 (tartrazine), FD&C Blue #1, flavors, gum acacia, maltodextrin, sorbitol, sucralose, sucrose, tocopherols

Questions or Comments?

1-800-897-7535 (English/Spanish) weekdays

Principal Display Panel

NDC 0135-0522-02

TUMS®

freshers®

ANTACID

Fast Relief, Fresh Breath

Cool Mint

CALCIUM CARBONATE

FAST ANTACID

COOLING TABS

25 CHEWABLE TABLETS

PAREVE

See Inside for Valuable Coupon!

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

Contains natural mint oils to help freshen breath.

Keep this outer packaging for complete labeling information.

www.tums.com

Gluten-Free

TUMS, FRESHERS and the logo device are registered trademarks of the GSK group of companies.

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2014 GlaxoSmithKline

103559PA

Principal Display Panel

NDC 0135-0541-03

TUMS

freshers®

ANTACID

CALCIUM CARBONATE

Spearmint

FAST ANTACID

COOLING TABS

TWIN PACK 2X25 CHEWABLE TABLETS

PAREVE

TUMS, FRESHERS and the logo device are registered trademarks of the GSK group of companies.

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

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2014 GSK

Blistercard: 103564PA

Inlay Card: 103565PA

TUMS  FRESHERS
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0522
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE 
STARCH, CORN 
FD&C BLUE NO. 1 
ACACIA 
MALTODEXTRIN 
SORBITOL 
SUCRALOSE 
SUCROSE 
TOCOPHEROL 
Product Characteristics
ColorWHITE (with blue speckles) Scoreno score
ShapeOVALSize13mm
FlavorPEPPERMINT (cool mint) Imprint CodeTUMS
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0522-012 TABLET, CHEWABLE in 1 POUCH
2NDC:0135-0522-021 BOTTLE in 1 CARTON
225 TABLET, CHEWABLE in 1 BOTTLE
3NDC:0135-0522-032 BOTTLE in 1 PACKAGE
325 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33102/02/2012
TUMS  FRESHERS
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0541
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (CALCIUM CATION and CARBONATE ION) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE 
STARCH, CORN 
FD&C YELLOW NO. 5 
FD&C BLUE NO. 1 
ACACIA 
MALTODEXTRIN 
SORBITOL 
SUCRALOSE 
SUCROSE 
TOCOPHEROL 
Product Characteristics
ColorWHITE (with green speckles) Scoreno score
ShapeOVALSize13mm
FlavorSPEARMINTImprint CodeTUMS
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0541-012 TABLET, CHEWABLE in 1 POUCH
2NDC:0135-0541-032 BOTTLE in 1 PACKAGE
2NDC:0135-0541-0225 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33108/01/2013
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 09/2014
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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