Label: TESTOSTERONE- testosterone, tablet

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated June 7, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Testosterone 30X.


  • PURPOSE

    INDICATIONS:  For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.


  • WARNINGS

    WARNINGS:  Not intended for persons under the age of 18.

    If pregnant or breast-feeding, do not use

    Consult a health professional prior to use if you have any pre-existing medical conditions or take any prescription medications.  Do not consume with any caffeine or stimulants.  Improper use will not improve results and is potentially hazardous to a person's health.

    Use only as directed.

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    To report a serious adverse event or obtain product information, please call 1-866-607-2768.


  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  Adults take 1-2 tablets daily.  Read warnings and use only as directed.


  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Creatine monohydrate, Croscarmellose sodium, Magnesium stearate, Mucrocrystalline cellulose, Silicon dioxide, Stearic acid.


  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.  In case of overdose, get medical help or contact a Poison Control Center right away.


  • INDICATIONS & USAGE

    INDICATIONS:  For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.


  • QUESTIONS

    Developed by and manufactured for:

    Zoe Processing

    4180 Pletezer Blvd.

    Rootstown, OH 44272

    WWW.TESTOSTERONERX.COM


  • PRINCIPAL DISPLAY PANEL

    Testosterone Tablets

    IUPAC Name: 17-hydroxy-10, 13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyc iopenta[a]phenanthren-3-one

    CAS Number: 58-22-0

    Chemical Formula: C19H2802

    Homeopathic

    50 Tablets

    Testosterone Tablets

  • INGREDIENTS AND APPEARANCE
    TESTOSTERONE 
    testosterone, tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0638
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CREATINE MONOHYDRATE (UNII: 9603LN7R2Q)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeOVAL (caplet) Size19mm
    FlavorImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0638-150 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/07/2011
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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