Label: TUMS CHEWY BITES BERRY SHAKE- calcium carbonate tablet, chewable

  • NDC Code(s): 0135-0184-01
  • 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 June 9, 2021

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

  • Active ingredient (per 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 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. Chew or crush tablets completely before swallowing.
    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 305 mg
    do not store above 25°C (77°F)
  • Inactive ingredients

    Acacia gum, alcohol, ammonium hydroxide, beeswax, carmine, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, ethyl alcohol, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methyl paraben, n-butyl alcohol, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sorbic acid, sorbitol, soybean oil, soy lecithin, sucrose, tertiary butylhydroquinone, titanium dioxide, vegetable oil

  • Questions or comments?

    Call 1-800-897-7535

  • Principal Display Panel

    NDC 0135-0184-01

    TUMS

    CALCIUM CARBONATE

    ANTACID

    Chewy Bites

    Berry Shake

    GOES TO WORK IN SECONDS!

    EXTRA STRENGTH 750

    32 CHEWABLE TABLETS

    Safety sealed –

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

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

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

    ©2020 GSK or licensor.

    Front Label: 1001083

    Back Label: 1001084

    TUMS Chewy Bites Berry Shake 32 ct
  • INGREDIENTS AND APPEARANCE
    TUMS CHEWY BITES  BERRY SHAKE
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0184
    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)  
    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. 6 (UNII: H77VEI93A8)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    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)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize19mm
    FlavorBERRY (Shake) Imprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0184-011 in 1 CARTON07/01/2021
    132 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/05/2021
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)