Label: MESIMA- phellinus linteus mycelium capsule

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

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Drug Label Information

Updated February 27, 2013

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  • ACTIVE INGREDIENT

    phellinus linteus mycelium
  • INACTIVE INGREDIENT

    lactose, dextrin
  • PURPOSE

    - effective in uterine discharge and bleeding, dysmenorrheal, intestinal bleeding and activation of GI system
    -improving the immune functions of cancer patients after surgical resection of stomach, colon, or liver
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    - effective in uterine discharge and bleeding, dysmenorrheal, intestinal bleeding, and activation of GI system, 550-1100mg twice a day before meals
    - effective in improving the immune functions of cancer patients after surgical resection of stomach, colon, or liver, 1100mg three times a day before meals
  • WARNINGS

    - GI system:  may cause nausea, vomiting, diarrhea, or abdominal discomfort
    - dizziness (one case), headache (one case), and constipation (three cases) were reported during clinical trials
  • DOSAGE & ADMINISTRATION

    for oral use only
  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    MESIMA  
    phellinus linteus mycelium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53144-1001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHELLINUS LINTEUS MYCELIUM (UNII: 40K19XJV3C) (PHELLINUS LINTEUS MYCELIUM - UNII:40K19XJV3C) PHELLINUS LINTEUS MYCELIUM1.1 
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    Product Characteristics
    Colorbrown (light brown) Scoreno score
    ShapeOVAL (tablet) Size15mm
    FlavorImprint Code 3;hp;x
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53144-1001-12 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/29/2012
    Labeler - Yein Trading & Global Co., Ltd (557803795)
    Registrant - Yein Trading & Global Co., Ltd (557803795)
    Establishment
    NameAddressID/FEIBusiness Operations
    Han Kook Sin Yak Pharmaceutical Co., Ltd.689277536manufacture(53144-1001)
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