Label: ENERGAIN- tribulus terrestris root granule

  • 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 February 15, 2012

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  • ACTIVE INGREDIENT

    active ingredient: tribulus terrestris extract powder
  • INACTIVE INGREDIENT

    guarana extract powder, silkworm powder, eucommia bark powder, lycium barbarum fruit powder, rubus coreanus fruit powder, red ginseng powder
  • PURPOSE

    helps with impotence, promote stamina, increase immunity, effective in improving blood circulation, helps strengthen endurance, anti-aging
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    take one pouch daily with water
  • WARNINGS

    if a fever occurs or you feel dizzy after taking this drugs, immediately stop taking
  • DOSAGE & ADMINISTRATION

    people with heart disease or allergies to comply with a doctor's prescription
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    ENERGAIN 
    tribulus terrestris root granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42707-2001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBULUS TERRESTRIS ROOT (UNII: 6WY8ROM74K) (TRIBULUS TERRESTRIS ROOT - UNII:6WY8ROM74K) TRIBULUS TERRESTRIS ROOT8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PAULLINIA CUPANA SEED (UNII: C21GE7524R)  
    PANAX GINSENG FRUIT (UNII: E35T4MOI3E)  
    EUCOMMIA ULMOIDES BARK (UNII: L878N1L0AR)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42707-2001-230 in 1 BOX
    1NDC:42707-2001-13 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/07/2012
    Labeler - Korea Genetic Pharm Co., Ltd (689828218)
    Registrant - Korea Genetic Pharm Co., Ltd (689828218)
    Establishment
    NameAddressID/FEIBusiness Operations
    Korea Genetic Pharm Co., Ltd 689828218manufacture