MALE ENDOCRINE AXIS DROPS 5019- male endocrine axis drops liquid

Male Endocrine Axis Drops by

Drug Labeling and Warnings

Male Endocrine Axis Drops by is a Homeopathic medication manufactured, distributed, or labeled by Professional Complementary Health Formulas, Natural Pharmaceutical Manufacturing LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Populus tremuloides 1X
Sabal serrulata 1X
Solidago virgaurea 2X
Pygeum africanum 3X
Sarsaparilla 3X
Zincum metallicum 3X
Damiana 4X
Adrenal 6X
Ferrum picricum 6X
Orchic 6X
Pituitary 6X
Prostate 6X
Selenium metallicum 6X

QUESTIONS

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

For the temporary relief of diminished sexual desire or performance, muscle weakness or decreased strength, sleep disturbances, weight gain, frequent or difficult urination, or fatigue.*

PURPOSE

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS

Consult a doctor if condition worsens or if symptoms persist. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

Keep out of the reach of children.

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

20% ethanol, purified water.

LABEL

Est 1985

Professional Formulas

Complementary Health

Male Endocrine Axis Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

INGREDIENTS AND APPEARANCE

MALE ENDOCRINE AXIS DROPS  5019
male endocrine axis drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63083-5019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID) (POPULUS TREMULOIDES BARK - UNII:5543O0CEID)	POPULUS TREMULOIDES BARK	1 [hp_X]  in 59 mL
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	1 [hp_X]  in 59 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	2 [hp_X]  in 59 mL
PYGEUM (UNII: 709HYI14M4) (PYGEUM - UNII:709HYI14M4)	PYGEUM	3 [hp_X]  in 59 mL
SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SMILAX ORNATA ROOT - UNII:2H1576D5WG)	SMILAX ORNATA ROOT	3 [hp_X]  in 59 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	3 [hp_X]  in 59 mL
TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ)	TURNERA DIFFUSA LEAFY TWIG	4 [hp_X]  in 59 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	6 [hp_X]  in 59 mL
FERRIC CATION (UNII: 91O4LML611) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	6 [hp_X]  in 59 mL
BOS TAURUS TESTICLE (UNII: PR4RXL6G2H) (BOS TAURUS TESTICLE - UNII:PR4RXL6G2H)	BOS TAURUS TESTICLE	6 [hp_X]  in 59 mL
BOS TAURUS PITUITARY GLAND, POSTERIOR (UNII: 7JM57I419K) (BOS TAURUS PITUITARY GLAND, POSTERIOR - UNII:7JM57I419K)	BOS TAURUS PITUITARY GLAND, POSTERIOR	6 [hp_X]  in 59 mL
BOS TAURUS PROSTATE GLAND (UNII: 1P66FXU2MW) (BOS TAURUS PROSTATE GLAND - UNII:1P66FXU2MW)	BOS TAURUS PROSTATE GLAND	6 [hp_X]  in 59 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	6 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63083-5019-2	59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/15/1985

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/15/1984

Labeler - Professional Complementary Health Formulas (167339027)

Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Pharmaceutical Manufacturing LLC		015624923	manufacture(63083-5019)