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

TUMS CHEWY BITES (CALCIUM CARBONATE) TABLET, CHEWABLE [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0135-0606-01, 0135-0606-02, 0135-0623-01
Set ID 72ac000c-90f7-42e2-88a6-740de114a954
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class
Product Number
Application Number PART331
  • Active ingredient (per tablet)

    Calcium Carbonate USP 750mg

  • 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 6 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 chewable tablet contains: elemental calcium 300mg
    do not store above 25°C (77°F)
  • Inactive ingredients

    acacia gum, alcohol, ammonium hydroxide, beeswax, caprylic/capric triglycerides, carmine, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, ethyl alcohol, FD&C blue #1 alum lake, FD&C blue #2 alum lake, FD&C red #40, FD&C red #40 alum lake, FD&C yellow #5 alum lake (tartrazine), FD&C yellow #6, FD&C yellow #6 alum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methyl paraben, modified corn starch, n-butyl alcohol, phosphoric acid, PVP, propyl paraben, propylene glycol, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soy bean oil, soy lecithin, sucrose, TBHQ, titanium dioxide, triacetin, vegetable oil

  • Questions?

    Call 1-800-897-7535

  • Principal Display Panel

    NDC 0135-0606-05

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    Chewy Bites

    Assorted Berries

    GOES TO WORK IN SECONDS!

    EXTRA STRENGTH 750

    54 CHEWABLE TABLETS

    Safety sealed –

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

    Distributed by:

    GSKConsumer Healthcare

    Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2020 GSK or licensor

    Front Label: 1000948

    Back Label: 1000949

    1000948 Tums Chewy Bites 54ct es750
  • INGREDIENTS AND APPEARANCE
    TUMS CHEWY BITES 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0606
    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
    ACACIA (UNII: 5C5403N26O)  
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    TERT-BUTYLHYDROQUINONE (UNII: C12674942B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorRED (red, pink, purple) Scoreno score
    ShapeROUNDSize19mm
    FlavorSTRAWBERRY (Assorted Berry: Strawberry, Raspberry, Mixed Berry) Imprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0606-0132 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2017
    2NDC:0135-0606-0260 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2017
    3NDC:0135-0606-048 in 1 BOTTLE; Type 0: Not a Combination Product01/02/2020
    4NDC:0135-0606-052 in 1 PACKAGE03/02/2021
    454 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/01/2017
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Specialty Minerals Incorporated796649390API MANUFACTURE(0135-0606)
    Establishment
    NameAddressID/FEIBusiness Operations
    GlaxoSmithKline Consumer Healthcare Holdings (US) LLC046877908LABEL(0135-0606) , PACK(0135-0606)