Label: TUMS CHEWY BITES- calcium carbonate tablet, chewable

  • NDC Code(s): 0135-0606-01, 0135-0606-02, 0135-0606-04, 0135-0606-05
  • 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 March 2, 2021

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

  • 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)