Label: TUMS EXTRA STRENGTH SUGAR-FREE- 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 September 24, 2020

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

  • Active ingredient (per tablet)

    Calcium carbonate USP 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 10 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 300 mg
    do not store above 25°C (77°F)
  • Inactive ingredients

    acacia gum, calcium stearate, FD&C red #40 alum lake, FD&C yellow #5 alum lake (tartrazine), flavors, sorbitol, sucralose

  • Questions or comments?

    Call toll-free 1-800-897-7535

  • Additional Information

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

    Gluten-Free

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    ©2020 GSK

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

  • Principal Display Panel

    NEW

    NDC 0135-0155-01

    TUMS®

    CALCIUM CARBONATE

    ANTACID

    GOES TO WORK IN SECONDS!

    SUGAR-FREE

    Melon Berry

    EXTRA STRENGTH 750

    80 CHEWABLE TABLETS

    Front Label: 106228XA

    Back Label: 62000000056184

    106228XA_Tums Sugar Free Melon Berry_80 ct.JPG
  • INGREDIENTS AND APPEARANCE
    TUMS  EXTRA STRENGTH SUGAR-FREE
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0155
    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)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorRED, YELLOWScoreno score
    ShapeROUNDSize15mm
    FlavorBERRY (Melon Berry: Strawberry-Banana, Raspberry, Watermelon) Imprint Code T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0155-0180 in 1 BOTTLE; Type 0: Not a Combination Product03/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/18/2018
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)