Label: TUMS- calcium carbonate tablet

  • NDC Code(s): 0135-1000-01, 0135-1000-02, 0135-1001-01, 0135-1001-02
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 October 8, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Calcium carbonate 750 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

    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

    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 300 mg, magnesium 10 mg
    store below 30oC (86oF)
  • Inactive ingredients (Assorted Berries)

    adipic acid, corn starch, crospovidone, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc

  • Inactive ingredient (Assorted Fruit)

    adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc

  • Questions?

    1-800-897-7535

  • Additional Information

    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

    Dist. by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2021 GSK or licensor.

  • PRINCIPAL DISPLAY PANEL

    NDC 0135-1000-01

    TUMS

    CALCIUM CARBONATE

    ANTACID

    Assorted Berries

    GOES TO WORK IN SECONDS!

    70 CHEWABLE TABLETS

    EXTRA STRENGTH 750

    Front Label: 1001343

    Back Label: 1001344

    Tums Chewable Assorted Berries 70 count label
  • Principal Display Panel

    NDC 0135-1001-01

    TUMS

    CALCIUM CARBONATE

    ANTACID

    Assorted Fruit

    GOES TO WORK IN SECONDS!

    70 CHEWABLE TABLETS

    EXTRA STRENGTH 750

    Front Label: 1001345

    Back Label: 1001346

    Tums Chewable Assorted Fruit 70 count label
  • INGREDIENTS AND APPEARANCE
    TUMS 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-1000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINK (Red(mauve), Blue(bluish)) Scoreno score
    ShapeROUNDSize16mm
    FlavorBERRY (assorted berries (strawberry, raspberry, wild berry) Imprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-1000-0170 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2021
    2NDC:0135-1000-0296 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33110/08/2021
    TUMS 
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-1001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPINK (Orange, Yellow, Green) Scoreno score
    ShapeROUNDSize16mm
    FlavorFRUIT (assorted fruit (cherry, orange, lemon, lime) Imprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-1001-0170 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2021
    2NDC:0135-1001-0296 in 1 BOTTLE; Type 0: Not a Combination Product10/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33110/08/2021
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)