Label: KOREA GONGJIN-DAN- panax ginseng fruit pellet

  • 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 June 22, 2012

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    active ingredient: korean red ginseng
  • INACTIVE INGREDIENT

    inactive ingredient: Water, Liriopis Tuber, Cervicornu Pavum, Angelicae gigantis Radix, Corni fructus, Gastrodiae Rhizoma,  Puerariae Radix,  Aurantii Nobilis Pericarpium, Maximowicziae Fructus, Helenii Radix,
    Aquilaiae lignum
  • PURPOSE

    ■Improve virility, male potency
    ■ Anti aging and precautionary approach to prevent the disease
    ■ Fast recovery from aftereffects from surgery and illness.
    ■ Remedy for mental and physical exhaustion,
    ■ Cure the innate aphylaxis
    ■ Alleviate the sluggish and tingling sense raised by circulatory disorder
    ■ Ease mental and emotional disorder caused by poor stamina and repressed stress.
    ■ Ease the nervosity, erethism and chronic fatigue
    ■ Remedy palpitation and insomnia

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    ■ A pellet per a day(morning time is preferable), chewing a pellet with lukewarm
    drinking water is recommended
    ■ No age limit for intake.
    ■ keep the product in refrigerator.

  • WARNINGS

    When using this product
    ■ If you are pregnant, nursing, taking any medications or planning any medical procedure, consult your doctor before
      use. Discontinue use and consult your doctor if any adverse reactions occur.
    ■ Please check the ingredients before taking if there are allergic or idiosyncratic symptoms
    ■ Do not take if the product of expiration date is over
  • DOSAGE & ADMINISTRATION

    ■ No any specific food is prohibited during dosage except for alcoholic beverage or
    Mung beans and it's processed foods if possible.
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    KOREA GONGJIN-DAN 
    panax ginseng fruit pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76401-1001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PANAX GINSENG FRUIT (UNII: E35T4MOI3E) (PANAX GINSENG FRUIT - UNII:E35T4MOI3E) PANAX GINSENG FRUIT229 mg  in 4 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN)  
    CORNUS OFFICINALIS FRUIT (UNII: 23NL8NQ187)  
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
    CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7)  
    KALOPANAX SEPTEMLOBUS BARK (UNII: 3PC02N4V3V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76401-1001-210 in 1 BOX
    1NDC:76401-1001-14 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/22/2012
    Labeler - Songjeongo OM Clinic (557804795)
    Registrant - Songjeongo OM Clinic (557804795)
    Establishment
    NameAddressID/FEIBusiness Operations
    Songjeongo OM Clinic557804795manufacture