Label: EQUATE ULTRA STRENGTH ANTACID CALCIUM CARBONATE TROPICAL FRUIT- antacid tablets 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 March 21, 2016

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

  • Active ingredient (per tablet)

    Calcium Carbonate USP 1000mg

  • 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 presentlytaking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

     
    do not take more than 7 tablets in 24 hours
     
    if pregnant do not take more than 5 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 tablet contains: elemental calcium 400mg
     
    store below 30°C (86°F).
  • Inactive ingredients

    adipic acid, dextrose, flavors, magnesium stearate, maltodextrin, red 40 lake, starch, sucralose, yellow 6 lake, yellow 10 lake.

    Questions?

    1-888-287-1915

    Safety sealed: Do not use if printed seal under cap is torn or missing

  • Package/Label Principal Display Panel

    NDC 49035-103-37

    equate™

    Compare to Tums® Ultra Strength Active Ingredient*

    Ultra Strength

    Antacid

    Calcium Carbonate

    Starts Working in Seconds to Relieve:

    Heartburn
    Acid indigestion
    Sour stomach

    Tropical Fruit Flavors

    1000 mg

    160 CHEWABLE TABLETS

    Gluten- Free

    Satisfaction guaranteed-

    For questions or comments, please call

    1-888-287-1915.

    Distributed by: Wal-Mart Stores, Inc.,

    Bentonville,AR 72716

    *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Tums®.


    equate Ultra Strength Antacid Calcium Carbonate
  • INGREDIENTS AND APPEARANCE
    EQUATE ULTRA STRENGTH ANTACID CALCIUM CARBONATE  TROPICAL FRUIT
    antacid tablets tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-103
    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
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorYELLOW, PINK, ORANGE, WHITEScoreno score
    ShapeROUNDSize19mm
    FlavorFRUIT (tropical fruit flavor) Imprint Code RP103
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-103-37160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33110/20/2015
    Labeler - Wal-Mart Stores,Inc., (051957769)