Label: CALCIUM ANTACID- calcium carbonate tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 26, 2022

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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: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: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, LLC078805287REPACK(48433-106)
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