Label: MAJOR REGULAR STRENGTH ASSORTED FLAVORS- antacid tablets tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • Active ingredient

    Calcium Carbonate USP 500mg

  • Purpose

    Antacid

  • Uses

    relieves:

    • heartburn

    • sour stomach

    • acid indigestion

    • 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 15 tablets in 24 hours
    •
    If pregnant do not take more than 10 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 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 200 mg
    •
    Store at room temperature. Keep the container tightly closed

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

  • 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.

  • Package/Label Principal Display Panel

    Compare to active ingredient in Regular Strength Tums®*

    MAJOR®

    NDC 0904-6412-92

    Regular Strength

    Antacid Tablets

    Calcium Carbonate 500mg

    Fast relief of upset stomach, heartburn, and acid indigestion

    Assorted Fruit Flavor

    Naturally & Artificially Flavored

    150 Chewable Tablets

    K PAREVE

    GLUTEN- FREE

    Distributed by: MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152, USA

    M-107 REV. 11/19

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

    Major Regular Strength Assorted Fruit 150 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    MAJOR REGULAR STRENGTH  ASSORTED FLAVORS
    antacid tablets tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6412
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 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
    ColorWHITEScoreno score
    ShapeROUNDSize16mm
    FlavorFRUITImprint Code RP101
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6412-92150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/12/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00108/12/2014
    Labeler - Major Pharmaceuticals (191427277)
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