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

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 February 27, 2013

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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
    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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