Label: PURE CALCIUM CALCIUM- calcium tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 21, 2010

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  • ACTIVE INGREDIENT

    Active ingredients: Calcium, Manganese, Vitamin D3
  • DESCRIPTION

    • Uses
    Calcium: Woman susceptible to osteoporosis with menopause
    Promote the bone growth of children and teenagers
    Supplement calcium during pregnancy and lactation
    Vitamin D: maintain blood levels of calcium
    Manganese: needed for healthy skin, bone, and cartilage
    formation, as well as glucose tolerance unconditioning
    of the retina

    • Warning
    , Patients with a history of idiosyncrasy and allergy may have
    a higher risk of a hypersensitivity, Please check the raw
    materials in this product

    • Direction
    , take 2 tablet daily. (can be tablet.)

    • Other Information
    , Keep at room temperature in a dark dry place
    . Keep out of reach of children
  • PRINCIPAL DISPLAY PANEL

    box label
  • PURPOSE

    • Uses
    Calcium: Woman susceptible to osteoporosis with menopause
    Promote the bone growth of children and teenagers
    Supplement calcium during pregnancy and lactation
    Vitamin D: maintain blood levels of calcium
    Manganese: needed for healthy skin, bone, and cartilage
    formation, as well as glucose tolerance unconditioning
    of the retina
  • KEEP OUT OF REACH OF CHILDREN

    • Other Information
    , Keep at room temperature in a dark dry place
    . Keep out of reach of children
  • INDICATIONS & USAGE

    • Direction
    , take 2 tablet daily. (can be tablet.)
  • WARNINGS

    • Warning
    , Patients with a history of idiosyncrasy and allergy may have
    a higher risk of a hypersensitivity, Please check the raw
    materials in this product

  • DOSAGE & ADMINISTRATION

    • Direction
    , take 2 tablet daily. (can be tablet.)
  • INACTIVE INGREDIENT

    Inactive ingredients: sorbitol, milk, cocoa, xylitol, magnesium, safflower, stevia, vitamin K1
  • INGREDIENTS AND APPEARANCE
    PURE CALCIUM  CALCIUM
    calcium tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51220-3001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM435 mg
    MANGANESE (UNII: 42Z2K6ZL8P) (MANGANESE - UNII:42Z2K6ZL8P) MANGANESE1.7 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL1.2 mg
    Product Characteristics
    Colorwhite (saimdang) Scoreno score
    ShapeOVAL (capsule) Size12mm
    FlavorImprint Code 3;hp;x
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51220-3001-1120 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/24/2010
    Labeler - Saimdang Cosmetics Co., Ltd (689191286)