STRENGTH M- aralia quinquefolia, avena sativa, damaina, l-arginne, epimedium, glutathion, l-leucine, l-ornithine, valine, testosterone, sabal serrulata, sepia, liquid
BioActive Nutritional, Inc.

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.

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Drug Facts:

ACTIVE INGREDIENTS:

Aralia Quinquefolia 3X, Avena Sativa 3X, Damiana 3X, L-Arginine 6X, Epimedium 6X, Glutathione 6X, L-Leucine 6X, L-Ornithine 6X, Valine 6X, Testosterone 12X, Sabal Serrulata 24X, Sepia 30X.

INDICATIONS:

For temporary relief of muscular exhaustion, debility after exercise and lowered vitality in the male after exercise.

WARNINGS:

If pregnant or breast-feeding, ask a health care professional before use.

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.

Store in cool, dry place.

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.

DIRECTIONS:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of muscular exhaustion, debility after exercise and lowered vitality in the male after exercise.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

BioActive Homeopathic
STRENGTH M
1 FL OZ (30 ml)

Strength M

STRENGTH M
aralia quinquefolia, avena sativa, damaina, l-arginne, epimedium, glutathion, l-leucine, l-ornithine, valine, testosterone, sabal serrulata, sepia, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0259
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q)	AMERICAN GINSENG	3 [hp_X] in 1 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	3 [hp_X] in 1 mL
TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ)	TURNERA DIFFUSA LEAFY TWIG	3 [hp_X] in 1 mL
ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F)	ARGININE	6 [hp_X] in 1 mL
EPIMEDIUM GRANDIFLORUM TOP (UNII: 137PC46F89) (EPIMEDIUM GRANDIFLORUM TOP - UNII:137PC46F89)	EPIMEDIUM GRANDIFLORUM TOP	6 [hp_X] in 1 mL
GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O)	GLUTATHIONE	6 [hp_X] in 1 mL
LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C)	LEUCINE	6 [hp_X] in 1 mL
ORNITHINE (UNII: E524N2IXA3) (ORNITHINE - UNII:E524N2IXA3)	ORNITHINE	6 [hp_X] in 1 mL
VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7)	VALINE	6 [hp_X] in 1 mL
TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)	TESTOSTERONE	12 [hp_X] in 1 mL
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	24 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0259-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	06/17/2014	11/10/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		06/17/2014	11/10/2020

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0259) , api manufacture(43857-0259) , label(43857-0259) , pack(43857-0259)

Revised: 12/2017

Document Id: 38140dba-d03d-4cbd-8e01-42f4c3b049ba

Set id: 4a977b8f-d2aa-49fc-9322-32d38bc3f08a

Version: 3

Effective Time: 20171206

BioActive Nutritional, Inc.