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 48433-106-01
Set ID 636a00a9-9df5-40cb-940a-61cc52016a1b
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 500 mg

  • Purpose

    Acid Indigestion, Heartburn, Sour & Upset Stomach

  • Uses

    relieves

    •
    heartburn
    •
    acid indigestion
    •
    sour stomach
    •
    upset stomach associated with these symptoms
  • Warnings

  • Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

    When Using

    do not take more than 15 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: 200mg

    Supplement Facts

    •
    Serving size 2 tablets
    •
    Servings per Container: 50
    •
    Amount Per Serving
    Calories: 5
    Calcium: 400mg(40%DV)
  • Inactive Ingredients

    Blue #1, dextrose, flavors, magnesium stearate, maltodextrin, red #40, yellow #6, yellow #10

    Packaged and Distributed by:

    Safecor Health, LLC
    317 New Boston Street, Suite 100

    Woburn, MA 01801

  • Package/Label Principal Display Panel

    SAFECOR HEALTH

    CALCIUM ANTACID

    Regular Strength

    500 mg

    NDC 48433-106-01

    Fruit Flavored Chewable Tablets

    Compare to Tums ® Active Ingredient *

    This package is not child resistant. For institutional use only.

    This product is not manufactured or distributed by GlaxoSmithKline, distributor of Tums®

    Questions or comments? Call 1-800-447-1006

    100 Unit Dose Chewable Tablets

    Calcium Antacid 500 mg Unit Dose Box Label
  • INGREDIENTS AND APPEARANCE
    CALCIUM ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-106(NDC:62211-219)
    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:48433-106-01100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product08/25/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33108/25/2014
    Labeler - Safecor Health, LLC (828269675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC828269675REPACK(48433-106)
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