Label: EXTRA STRENGTH ANTACID- calcium carbonate tablet, chewable

  • NDC Code(s): 51013-323-54
  • Packager: PuraCap Pharmaceutical LLC
  • 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 December 13, 2017

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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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