Label: TUMS CHEWY BITES- calcium carbonate tablet, chewable

  • NDC Code(s): 0135-0183-01, 0135-0183-02
  • 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 December 10, 2020

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

  • Active ingredient (per tablet)

    Calcium Carbonate 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 4 tablets in 24 hours
    if pregnant do not take more than 4 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 above 25°C (77°F)
  • Inactive Ingredients (2 ct. Pouch)

    alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no.1 aluminum lake, FD&C red no. 40*, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine)*, FD&C yellow no. 6 aluminum lake, flavors, gum arabic, isopropyl alcohol, lecithin, maltodextrin, medium chain triglycerides, methylparaben*, modified starch, n-butyl alcohol, phosphoric acid*, polyvinylpyrrolidone*, propylene glycol, propylparaben*, purified water, shellac, sodium benzoate*, sorbic acid, sorbitol, soybean oil, sucrose, tert-butylhydroquinone, titanium dioxide, vegetable oil

    *contains one or more of these ingredients

  • Inactive Ingredients (28 ct. Bottle)

    alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, coconut oil, corn starch, corn syrup, dextrin, ethyl acetate, FD&C blue no.1 aluminum lake, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, flavors, gum arabic, isopropyl alcohol, lecithin, maltodextrin, medium chain triglycerides, methylparaben, modified starch, n-butyl alcohol, phosphoric acid, polyvinylpyrrolidone, propylene glycol, propylparaben, purified water, shellac, sodium benzoate, sorbic acid, sorbitol, soybean oil, sucrose, tert-butylhydroquinone, titanium dioxide, vegetable oil

  • Questions?

    Call 1-800-897-7535

  • Principal Display Panel

    NEW

    NDC 0135-0183-01

    TUMS

    CALCIUM CARBONATE

    ANTACID

    Chewy Bites

    COOLING SENSATION*

    FRUIT FUSION

    GOES TO WORK IN SECONDS!

    ULTRA STRENGTH 1000

    28 CHEWABLE TABLETS

    *Cooling sensation refers only to our unique cooling flavor(s).

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

    Dist. by: GSKConsumer Healthcare

    Warren, NJ 07059

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

    ©2018 GSK or its licensor.

    106487XA

    106486XA_TUMS Chewy Bites Fruit Fusion_28 ct.JPG
  • INGREDIENTS AND APPEARANCE
    TUMS CHEWY BITES 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0183
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ACACIA (UNII: 5C5403N26O)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCROSE (UNII: C151H8M554)  
    TERT-BUTYLHYDROQUINONE (UNII: C12674942B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    ColorGREEN (Green/Blue/Red) , BLUE (Green/Blue/Red) , RED (Green/Blue/Red) Scoreno score
    ShapeROUNDSize19mm
    FlavorFRUIT (Fruit Fusion) Imprint Code TC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0183-0128 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2019
    2NDC:0135-0183-022 in 1 POUCH; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/01/2019
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)