CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]

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CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [ALLEGIANT HEALTH]
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NDC 69168-219-02, 69168-219-50
Set ID 551d6135-2650-4c27-a20d-d56a9aba7b71
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredient (in each tablet)

    Calcium Carbonate 500 mg

  • 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

    • have kidney disease
    • are 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.

    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

    • store at 15º-30ºC (59º-86ºF) 
    • do not use if imprinted safety seal under cap is broken or missing
    • Calcium content per tablet: 200mg
  • Inactive ingredients

    assorted flavors, D&C yellow #10 aluminum lake, dextrose, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, mineral oil

  • Package/Label Principal Display Panel

    SODIUM FREE

    Health A2Z®

    CALCIUM ANTACID
    REGULAR STRENGTH
    500 mg
    Calcium Supplement

    Fast Relief of...

    • Sour & Upset Stomach
    • Acid Indigestion
    • Heartburn 

    *Compare to Tums® Active Ingredient

    Assorted Fruit

    Chewable Tablets

    Calcium Antacid 500mg

    Calcium Antacid 500mg

  • INGREDIENTS AND APPEARANCE
    CALCIUM ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-219
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorYELLOW, ORANGE, PINK, GREENScoreno score
    ShapeROUNDSize16mm
    FlavorLIME, CHERRY, ORANGE, LEMONImprint Code AZ;024
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-219-02150 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
    2NDC:69168-219-5050 in 1 BOTTLE; Type 0: Not a Combination Product12/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33112/16/2014
    Labeler - Allegiant Health (079501930)
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