Label: IMG - phellinus linteus mycelium tablet 

  • Label RSS
  • NDC Code(s): 53144-3001-1
  • Packager: Yein Trading & Global Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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  • ACTIVE INGREDIENT

    phellinus linteus mycelium
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  • 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%

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  • PURPOSE

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

    keep out of reach of the children
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  • 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
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  • 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
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  • 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
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  • INGREDIENTS AND APPEARANCE
    IMG 
    phellinus linteus mycelium tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53144-3001
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHELLINUS LINTEUS MYCELIUM (PHELLINUS LINTEUS MYCELIUM) PHELLINUS LINTEUS MYCELIUM 0.022 
    Inactive Ingredients
    Ingredient Name Strength
    ZINC GLUCONATE  
    ASCORBIC ACID  
    LACTOSE  
    REISHI  
    TRAMETES VERSICOLOR FRUITING BODY  
    GRIFOLA FRONDOSA WHOLE  
    HYPROMELLOSES  
    CARBOXYMETHYLCELLULOSE CALCIUM  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color brown (light brown) Score no score
    Shape OVAL (pill) Size 15mm
    Flavor Imprint Code 3;hp;x
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53144-3001-1 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/16/2013
    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(53144-3001)
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