Label: CALCIUM CARBONATE tablet

  • 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, 2012

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  • Active Ingredient

    (in each tablet)

    Calcium carbonate 10 gr (648 mg)

  • Purpose

    Antacid

  • Use

    relieves

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

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

    symptoms last more than 2 weeks. Stop use and ask a doctor if

    , ask a health professional before use. If pregnant or breast-feeding

    Keep out of reach of children.

  • Directions

    • take one to four tablets daily
    • do not take more than 4 tablets in 24 hours
    • do not use the maximum dosage for more than 2 weeks
  • Other Information

    • Each tablet contains: calcium 260 mg
    • store at room temperature 15°-30°C (59°-86°F)
  • Inactive Ingredients

    croscarmellose sodium, magnesium sterate, maltodextrin, microcrystalline cellulose, stearic acid

  • Questions or Comments

    Call Monday – Friday, 9 am – 5 pm ET 1-800-645-2158,

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    This is a bulk pakage, dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

    Mfd for: Rugby Laboratories,Inc

  • CALCIUM CARBONATE TABLET

    Label Image
  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE  
    calcium carbonate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68151-0012(NDC:0536-3414)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE648 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITE (off white) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AP;025
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68151-0012-11 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/12/1999
    Labeler - Carilion Materials Management (079239644)
    Registrant - Carilion Materials Management (079239644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carilion Materials Management079239644REPACK(68151-0012)
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