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 0135-0183-01, 0135-0183-02
Set ID 5090f60f-fa98-470b-bafd-bb64e6b28fcc
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 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)

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