Label: MESIMA - phellinus linteus mycelium capsule

  • NDC Code(s): 53144-1001-1
  • Packager: Yein Trading & Global Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 02/13

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  • ACTIVE INGREDIENT

    phellinus linteus mycelium
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  • INACTIVE INGREDIENT

    lactose, dextrin
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  • 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
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  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
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  • 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
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  • 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
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  • DOSAGE & ADMINISTRATION

    for oral use only
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  • INGREDIENTS AND APPEARANCE
    MESIMA  
    phellinus linteus mycelium capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53144-1001
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHELLINUS LINTEUS MYCELIUM (UNII: 40K19XJV3C) (PHELLINUS LINTEUS MYCELIUM - UNII:40K19XJV3C) PHELLINUS LINTEUS MYCELIUM 1.1 
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE (UNII: J2B2A4N98G)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    Product Characteristics
    Color brown (light brown) Score no score
    Shape OVAL (tablet) Size 15mm
    Flavor Imprint Code 3;hp;x
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53144-1001-1 2 in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/29/2012
    Labeler - Yein Trading & Global Co., Ltd (557803795)
    Registrant - Yein Trading & Global Co., Ltd (557803795)
    Establishment
    Name Address ID/FEI Business Operations
    Han Kook Sin Yak Pharmaceutical Co., Ltd. 689277536 manufacture(53144-1001)
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