Label: TUMS SMOOTHIES- 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 December 9, 2020

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 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
    do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
  • Other information

    each tablet contains: elemental calcium 300mg
    do not store above 25oC (77oF). Keep the container tightly closed.
  • Inactive ingredients

    acacia, adipic acid, calcium stearate, dextrose, FD&C red no. 40 aluminum lake, flavors, guar gum, microcrystalline cellulose, sorbitol

  • Questions or comments?

    1-800-897-7535

  • Principal Display Panel

    NDC 0135-0227-01

    TUMS

    CALCIUM CARBONATE

    ANTACID

    Smoothies

    Strawberry

    SMOOTH DISSOLVE

    EXTRA STRENGTH 750

    GOES TO WORK IN SECONDS!

    60CHEWABLE TABLETS

    Only Available at DOLLAR GENERAL

    PAREVE

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

    Dist. By: GSK CH

    Warren, NJ 07059

    ©2019 GSK or licensor.

    Front Panel 1000278

    1000278_Tums Smoothies Dollar General_60ct.JPG
  • INGREDIENTS AND APPEARANCE
    TUMS  SMOOTHIES
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0227
    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)  
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GUAR GUM (UNII: E89I1637KE)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorPINK (dark pink) Scoreno score
    ShapeROUNDSize19mm
    FlavorSTRAWBERRYImprint Code TUMS;SD
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0227-0160 in 1 BOTTLE; Type 0: Not a Combination Product10/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33110/07/2019
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)