CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]

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CALCIUM ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [SAFECOR HEALTH, LLC]
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NDC 48433-107-01, 48433-107-10
Set ID 3c2efeee-7e66-4b2b-8fc9-5e68f6076b0b
Category HUMAN OTC DRUG LABEL
Packager Safecor Health, LLC
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredient

    Calcium Carbonate 750 mg

  • Purpose

    Acid Indigestion, Heartburn, Sour & Upset Stomach

  • Uses

    relieves

    •
    heartburn
    •
    acid indigestion
    •
    sour stomach
    •
    upset stomach due to these symptoms
  • Warnings

  • Ask a doctor or pharmacist before use if you are

  • When Using

    do not take more than 10 tablets in a 24 hour period or use the maximum dosage of this product for more than two weeks.

  • Keep Out of Reach of Children

  • Directions

    •
    chew 2-4 tablets as symptoms occur, repeat hourly if needed

    Other Information

    •
    store at 59°-86°F
    •
    do not use if imprinted safety seal under cap is broken or missing
    •
    Calcium content per tablet: 300 mg

    Supplement Facts

    •
    Serving size 2 tablets
    •
    Servings per Container: 50
    •
    Amount Per Serving
    Calories: 10
    Calcium: 600 mg(60%DV)
  • Inactive Ingredients

    dextrose, FD&CBlue #1, FD&C Red #40, flavors, magnesium stearate, maltodextrin

    Packaged and Distributed by:

    Safecor Health, LLC
    Woburn, MA 01801

  • Package/Label Principal Display Panel

    Sodium Free

    CALCIUM ANTACID

    Extra Strength

    750 mg

    Assorted Berry flavor Chewable Tablets

    Calcium Antacid 750 mg UD box label
  • INGREDIENTS AND APPEARANCE
    CALCIUM ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-107(NDC:62211-229)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorGRAY, RED, PURPLE, ORANGEScoreno score
    ShapeROUNDSize16mm
    FlavorLIME, CHERRY, ORANGE, LEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48433-107-10100 in 1 BOX, UNIT-DOSE10/01/2014
    1NDC:48433-107-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33110/01/2014
    Labeler - Safecor Health, LLC (828269675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC828269675REPACK(48433-107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC078805287REPACK(48433-107)
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