Label: ULTRA STRENGTH ANTACID ASSORTED FRUIT- 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 4, 2019

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  • 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 presently taking 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 swallow tablets whole.
    •
    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 at room temperature. Keep the container tightly closed.
  • Inactive ingredients

    adipic acid, D&C Red No. 27 Lake, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

    Questions?

    1-866-467-2748

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

  • Package/Label Principal Display Panel

    NDC 49035-169-16

    equate™

    Compare to the active ingredient in Ultra Strength Tums®

    ULTRA STRENGTH

    Antacid Tablets

    Calcium Carbonate 1000 mg

    Fast Relief of Upset Stomach, Heartburn and Acid Indigestion

    Assorted Fruit Flavors

    Naturally and Artificially Flavored

    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®.

    Twin Pack Ultra Strength Antacid Tablets
  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH ANTACID  ASSORTED FRUIT
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-169
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorRED, GREEN, YELLOW, ORANGEScoreno score
    ShapeROUNDSize19mm
    FlavorFRUIT (assorted fruit) Imprint Code RP103
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-169-16160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/25/2019
    Labeler - Wal-Mart Stores,Inc., (051957769)
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