Label: SOMA CIRCUM- clove pill

  • 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 May 6, 2013

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  • ACTIVE INGREDIENT

    clove


  • INACTIVE INGREDIENT

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


  • PURPOSE

    To help the treatment of menopausal disorder, menstrual pain, menstrual irregularity, infertility, cold hands and feet syndrome, insomnia, depression, alopecia and aging

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

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



  • 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.



  • DOSAGE & ADMINISTRATION

    for oral use only


  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    SOMA CIRCUM 
    clove pill
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58370-1010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOVE (UNII: K48IKT5321) (CLOVE - UNII:K48IKT5321) CLOVE0.0275 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ARALIA CORDATA ROOT (UNII: 6KW7950A8P)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    CNIDIUM OFFICINALE WHOLE (UNII: E9V83DB6BY)  
    CINNAMON (UNII: 5S29HWU6QB)  
    MORUS AUSTRALIS LEAF (UNII: IR0M74L573)  
    ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    ACORUS GRAMINEUS ROOT (UNII: Z60N6Q6E19)  
    PEPPERS (UNII: T5KDM4J239)  
    ZEDOARY (UNII: 123C43G128)  
    POLYGONUM CUSPIDATUM WHOLE (UNII: 1VDG5Y5HS6)  
    TRAMETES VERSICOLOR FRUITING BODY (UNII: 4C900477MT)  
    CARAMEL (UNII: T9D99G2B1R)  
    Product Characteristics
    Colorbrown (brown) Scoreno score
    ShapeROUND (pill) Size6mm
    FlavorImprint Code 3;hp;x
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58370-1010-175 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/06/2013
    Labeler - SOMA Biotechnology Co., Ltd (688387576)
    Registrant - SOMA Biotechnology Co., Ltd (688387576)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMA Biotechnology Co., Ltd688387576manufacture(58370-1010)
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