Label: SOMA HYULGIHWAN GOLD - asian ginseng pill 

  • NDC Code(s): 58370-1013-1
  • Packager: SOMA Biotechnology 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 11/13

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

  • ACTIVE INGREDIENT

    ginseng powder


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  • INACTIVE INGREDIENT

    coriolus versicolorr, licorice, aralia continentalis, houttuynia cortata, cnidium officinale, cinnamon bark, houttuynia, mulberry leaf, astragalus membranaceus, gigantic angelica, sweet rush, pepper, bongchul, plueropterus multiflorus


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  • PURPOSE

    -strengthen blood circulation and immunity
    -give an energy for human body
    -create a nerve cell


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  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


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  • INDICATIONS & USAGE

    - Take 2 times a day
    - adults 5~7 pills
    - seniors:  3~5 pills
    - children:  1~3 pills



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  • WARNINGS

     If you have a cardiac disorder or cerebrovascular disease or you are a long-term medicated patient, gradually increase/reduce the dosage from 1 to 3 pills with a week interval.
    - Ask a doctor before you take more than 8 pills.
    - Do not exceed 8 pills if you do not know your constitution.



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  • DOSAGE & ADMINISTRATION

    for oral use only


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  • INGREDIENTS AND APPEARANCE
    SOMA HYULGIHWAN GOLD 
    clove pill
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58370-1013
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASIAN GINSENG (ASIAN GINSENG) ASIAN GINSENG 0.0567 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CLOVE  
    GLYCYRRHIZA GLABRA  
    ARALIA CORDATA ROOT  
    HOUTTUYNIA CORDATA FLOWERING TOP  
    CNIDIUM OFFICINALE WHOLE  
    CINNAMON  
    MORUS AUSTRALIS LEAF  
    ASTRAGALUS PROPINQUUS ROOT  
    ANGELICA SINENSIS ROOT  
    ACORUS GRAMINEUS ROOT  
    PEPPERS  
    ZEDOARY  
    POLYGONUM CUSPIDATUM WHOLE  
    TRAMETES VERSICOLOR FRUITING BODY  
    CARAMEL  
    Product Characteristics
    Color brown (brown) Score no score
    Shape ROUND (pill) Size 6mm
    Flavor Imprint Code 3;hp;x
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58370-1013-1 75 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/14/2013
    Labeler - SOMA Biotechnology Co., Ltd (688387576)
    Registrant - SOMA Biotechnology Co., Ltd (688387576)
    Establishment
    Name Address ID/FEI Business Operations
    SOMA Biotechnology Co., Ltd 688387576 manufacture(58370-1013)
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