EXTRA STRENGTH ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [PURACAP PHARMACEUTICAL LLC]

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  • EXTRA STRENGTH ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [PURACAP PHARMACEUTICAL LLC]

EXTRA STRENGTH ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [PURACAP PHARMACEUTICAL LLC]
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NDC 51013-323-54
Set ID 80509620-a3d1-49d5-b2e3-bff61ef4583d
Category HUMAN OTC DRUG LABEL
Packager PuraCap Pharmaceutical LLC
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredient (per tablet)

    Calcium Carbonate USP 750 mg

  • Purpose

    Antacid

  • Uses

    relieves

    • heartburn
    • acid indigestion
    • sour stomach
    • 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 10 tablets in 24 hours
    • if pregnant do not take more than 6 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

    • each tablet contains: calcium 300 mg
    • store at room temperature 15° - 30°C (59° - 86°F)
  • Inactive ingredients

    dextrose, flavor (peppermint), maltodextrin, magnesium stearate

  • Questions or comments?

    Call toll free: 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL

    Extra Strength Antacid Tablets

    30 Tablets   15 Pouches (2 Tablets per Pouch)

    NDC 51013-323-54

    CVSF38-00

    CVSB38-00

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-323
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION750 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize16mm
    FlavorPEPPERMINTImprint Code AP;052
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51013-323-5415 in 1 CARTON12/13/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/13/2017
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(51013-323)
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