Label: TUMS CHEWY BITES- calcium carbonate tablet, chewable

  • 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 May 30, 2019

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  • 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 INGREDIENT

    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 #1 alum lake, FD&C blue #2 alum lake, FD&C red #40 alum lake, FD&C yellow #6 alum lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, n-butyl alcohol, phosphoric acid, propylparaben, propylene glycol, purified water, shellac, sorbic acid, sorbitol, soybean oil, soy lecithin, sucrose, TBHQ, titanium dioxide, vegetable oil

  • Questions?

    Call 1-800-897-7535

  • Principal Display Panel

    Handy Solutions® Guarantee If dissatisfied with this product, return it with a brief explanation to 5330 Fox Street, Denver, CO 80216. We'll replace it free of charge and refund your postage. You may also call 1-800-525-5097 for customer service, 9am to 4pm MST, weekdays or email us at customerservice@navajoinc.com.
    Visit us on the web at www.navajoinc.com

    Packaged and Distributed by
    Navajo Mfg. Co. Inc. with permission
    of GSK Consumer Healthcare
    ©2019 GSK group of companies
    or its licensor.
    All rights reserved.

    Tums Chewy Bites

  • INGREDIENTS AND APPEARANCE
    TUMS CHEWY BITES 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-191(NDC:0135-0618)
    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)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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
    ColorpurpleScoreno score
    ShapeROUNDSize19mm
    FlavorRASPBERRY (Mixed berry: Raspberry and Blueberry) Imprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-191-011 in 1 CARTON05/30/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33105/30/2019
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-191)
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