Label: TUMS- calcium carbonate tablet

  • Category: HUMAN OTC DRUG LABEL

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 Label Information

Updated June 8, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (per tablet)

    Calcium Carbonate USP 500 mg

  • Purpose

    Antacid

  • Uses

    relieves

    heartburn
    acid indigestion
    sour stomach
    upset stomach associated with these symptoms
  • Warnings

    Ask a doctor or pharmacist before use if you are

    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 30oC (86oF)
  • Inactive ingredients (assorted fruit)

    Adipic acid, corn starch, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #5 (tartrazine) lake, FD&C yellow #6 lake, flavors, mineral oil, sodium polyphosphate, sucrose, talc

  • Inactive ingredient (peppermint)

    corn starch, flavor, mineral oil, sodium polyphosphate, sucrose, talc

  • Questions?

    1-800-897-7535

    weekdays

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

    Gluten-Free

    www.tums.com

    GlaxoSmithKline

    Moon Twp, PA 15108

  • PRINCIPAL DISPLAY PANEL

    NDC 0135-0071-27

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    REGULAR STRENGTH 500

    Goes to Work in Seconds!

    Assorted Fruit

    150 CHEWABLE TABLETS

    PAREVE

    ©2014 GSK

    Front Label: 103784XA

    Back Label: 103783XA

    Tums Regular Assorted Fruit 150 count label
  • Principal Display Panel

    NDC 0135-0070-27

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    REGULAR STRENGTH 500

    Goes to Work in Seconds!

    Peppermint

    150 CHEWABLE TABLETS

    PAREVE

    ©2014 GSK

    Front Label: 103781XA

    Back Label: 103780XA

    Tums Regular Peppermint 150 count label
  • INGREDIENTS AND APPEARANCE
    TUMS 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0071
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINK (orange, yellow, green) Scoreno score
    ShapeROUNDSize16mm
    FlavorCHERRY (assorted fruit, orange, lemon, lime) Imprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0071-27150 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2010
    2NDC:0135-0071-4812 in 1 PACKAGE; Type 0: Not a Combination Product03/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/10/2010
    TUMS 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0070
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize16mm
    FlavorPEPPERMINTImprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0070-033 in 1 CELLO PACK03/10/2010
    112 in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:0135-0070-27150 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2010
    3NDC:0135-0070-4812 in 1 PACKAGE; Type 0: Not a Combination Product03/10/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/10/2010
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)