Label: BONE CARE- atractylodes lancea root tablet

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

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Drug Label Information

Updated June 6, 2012

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  • ACTIVE INGREDIENT

    active ingredient: atractylodis rhizoma
  • INACTIVE INGREDIENT

    inactive ingredient: siberian chrysanthemum, puerariae radix, rehmanniae radix et rhizoma preparata, kalopnacis cortex, zanthoxyli fructus, acanthopanax root bark, achyranthis radix, phellinus linteus teng
  • PURPOSE

    helpful for the treatment of neuralgia, rheumatoid arthritis, thyroid, sciatica
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    take 3 times a day after meals with warm water


  • WARNINGS

    keep in a dry, cool place
    keep away from direct sunlight

  • DOSAGE & ADMINISTRATION

    do not take if you are pregnant
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    BONE CARE 
    atractylodes lancea root tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42469-1001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O) (ATRACTYLODES LANCEA ROOT - UNII:CAZ6282J2O) ATRACTYLODES LANCEA ROOT170 mg
    Inactive Ingredients
    Ingredient NameStrength
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    KALOPANAX SEPTEMLOBUS BARK (UNII: 3PC02N4V3V)  
    ZANTHOXYLUM SCHINIFOLIUM WHOLE (UNII: M8QGZ6O788)  
    ELEUTHEROCOCCUS SESSILIFLORUS WHOLE (UNII: 1LJK2AXF5I)  
    ACHYRANTHES JAPONICA WHOLE (UNII: F6490528HU)  
    PHELLINUS LINTEUS WHOLE (UNII: YVO92B1UCA)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeOVAL (tablet) Size20mm
    FlavorImprint Code 3;hp;x
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42469-1001-190 in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/04/2012
    Labeler - Evercarepharm Co., Ltd (557812798)
    Registrant - Evercarepharm Co., Ltd (557812798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Evercarepharm Co., Ltd557812798manufacture
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