MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]

MAJOR REGULAR STRENGTH ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]
PDF | XML

NDC 0904-6412-92
Set ID 2ba0eeb2-7048-4259-83d5-9f4ec1c92d32
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART331
  • 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®

    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 finalpart33108/12/2014
    Labeler - Major Pharmaceuticals (191427277)