Label: TESTOSTERONE - testosterone tablet
- NDC Code(s): 57520-0153-1
- Packager: Apothecca Company
- 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.
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- ACTIVE INGREDIENT
ACTIVE INGREDIENTS: Testosterone 30X.Close
INDICATIONS: For temporary relief of sexual debility from nervous prostration, for enhancing sexual function, nervous exhaustion causing lack of sexual desire.Close
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, microcrystalline cellulose, Silicon dioxide.
- 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.
Developed and manufactured for:
4180 Pletezer Blvd
Rootstown, OH 44272
- PRINCIPAL DISPLAY PANEL
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
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57520-0153 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE 30 [hp_X] in 5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CREATINE MONOHYDRATE (UNII: 9603LN7R2Q) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 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