TUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

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TUMS ULTRA (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0135-0610-01, 0135-0610-02, 0135-0612-01, 0135-0612-02
Set ID ee3faeab-4cea-4852-9ddf-901a346c092a
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredient (per tablet)

    Calcium Carbonate USP 1000 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 7 tablets in 24 hours
    •
    if pregnant do not take more than 5 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 2-3 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 400mg
    •
    do not store below 25oC (77oF)

     

  • Inactive ingredients (Tropical Fruit)

    cellulose, dextrose, FD&C red #40 alum lake, FD&C yellow #5 alum lake (tartrazine), FD&C yellow #6 alum lake, flavor, maltodextrin, mineral oil, polyethylene glycol, talc

  • Inactive ingredient (Mint)

    cellulose, dextrose, flavor, maltodextrin, mineral oil, polyethylene glycol, talc

  • Questions?

    1-800-897-7535

  • Principal Display Panel

    NDC 0135-0610-01

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    GOES TO WORK IN SECONDS!

    TROPICAL FRUIT

    ULTRA STRENGTH 1000

    72 CHEWABLE TABLETS

    ©2014 GSK

    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.

    Dist. by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2014 GSK or its licensor

    105439XA (Front Label)

    105440XA (Back Label)

    Tums Ultra Tropical Fruit 72 count front label
  • Principal Display Panel

    NDC 0135-0612-01

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    GOES TO WORK IN SECONDS!

    MINT

    ULTRA STRENGTH 1000

    72 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.

    Dist. by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2014 GSK or its licensor

    105430XA (Front Label)

    105431XA (Back Label)

    Tums Ultra Mint 72 count front label
  • INGREDIENTS AND APPEARANCE
    TUMS  ULTRA
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0610
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorRED (red, yellow, orange, off white) Scoreno score
    ShapeROUNDSize19mm
    FlavorTROPICAL FRUIT PUNCH (tropical fruit: tropical punch, banana, tropical orange, pineapple) Imprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0610-0172 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2016
    2NDC:0135-0610-02160 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33109/01/2016
    TUMS  ULTRA
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0612
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize19mm
    FlavorPEPPERMINTImprint Code TUMS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0612-0172 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2016
    2NDC:0135-0612-02160 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33109/01/2016
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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