Label: TESTOSTERONE - testosterone tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 06/11

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Testosterone 30X.

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  • PURPOSE

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

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  • 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.


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  • DOSAGE & ADMINISTRATION

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


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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Creatine monohydrate, Croscarmellose sodium, Magnesium stearate, microcrystalline cellulose, Silicon dioxide.


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  • 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.


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  • INDICATIONS & USAGE

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


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  • QUESTIONS

    Developed and manufactured for:

    Zoe Processing

    4180 Pletezer Blvd

    Rootstown, OH 44272

    WWW.TESTOSTERONERX.COM


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  • 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

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  • INGREDIENTS AND APPEARANCE
    TESTOSTERONE  
    testosterone, tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57520-0153
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TESTOSTERONE (TESTOSTERONE) TESTOSTERONE 30 [hp_X]  in 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    CREATINE MONOHYDRATE  
    CELLULOSE, MICROCRYSTALLINE  
    Product Characteristics
    Color white (white) Score no score
    Shape OVAL (large caplet) Size 22mm
    Flavor Imprint Code 0
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57520-0153-1 5 mg in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 05/10/2010 11/10/2015
    Labeler - Apothecca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture
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