Label: IMG- phellinus linteus mycelium tablet

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated February 26, 2013

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  • ACTIVE INGREDIENT

    phellinus linteus mycelium
  • INACTIVE INGREDIENT

    Zinc gluconate 3% (14.34% as Zinc), Vitamin C 10% (100% as vitamin C), Lactose 41%, Cordyceps militaris extract powder (mycelium culture) 6%, Chaga mushroom extract powder (mycelium culture) 6%, Ganoderma lucidum extract powder (mycelium culture) 6%, Trametes versicolor extract powder (mycelium culture) 6%, Grifola frondosa (mycelium culture) 6%, Hydroxypropylmethyl-cellulose 4%, Cultured Wild ginseng root powder 3%, Carboxymethylcellulose calcium 2%, Magnesium stearate 1%

  • PURPOSE

    antitumor effect
    prophylactic effect
    immunostimulating effect
    synergistic effect
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    1. ulterine hemorrhage and hysterorrhea, dysmenorrhea, intestinal hemorrhage, activation of five organs and stomach function, detoxication
    2. reinforcement of immune function by administration in parallel with any chemical therapy after any excising operation form the patient with cancer in digestive system or liver
  • WARNINGS

    - digestive system:  occasionally, vomiturition, vomiting, loss of appetite and diarrhea might occur, and infrequently malaise in stomach might take place
    - the others:  dizziness (1 case), headache (1 case), constipation (3 cases) were reported in clinical test of this medicine
  • DOSAGE & ADMINISTRATION

    - uterine hemorrhage and hysterorrhea, dysmenorrhea, intestinal hemorrhage, activation of five organs and stomach function, detoxication : as a phellinus linteus mycelia extracts, administer 550~1100mg 2 times per a day before having a meal by mouth
    - reinforcement of immune function by administration in parallel with any chemical therapy after any excising operation for the patient with cancer in digestive system or liver :  as a phellinus linteus mycelia extracts, administer 1100mg 3 times per a day after having a meal by mouth
  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    IMG 
    phellinus linteus mycelium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53144-3001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHELLINUS LINTEUS MYCELIUM (UNII: 40K19XJV3C) (PHELLINUS LINTEUS MYCELIUM - UNII:40K19XJV3C) PHELLINUS LINTEUS MYCELIUM0.022 
    Inactive Ingredients
    Ingredient NameStrength
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    LACTOSE (UNII: J2B2A4N98G)  
    REISHI (UNII: TKD8LH0X2Z)  
    TRAMETES VERSICOLOR FRUITING BODY (UNII: 4C900477MT)  
    GRIFOLA FRONDOSA WHOLE (UNII: O238UC53ET)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorbrown (light brown) Scoreno score
    ShapeOVAL (pill) Size15mm
    FlavorImprint Code 3;hp;x
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53144-3001-160 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/16/2013
    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(53144-3001)
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