Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

MAMMARYPLEX- echinacea, hydrastis canadensis, myrrha, phytolacca decandra, trigonella foenum graecum, lymph, spleen, bryonia, bufo rana, conium maculatum, lac caninum, lachesis mutus, silicea, mammary gland, 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

Echinacea 3X, Hydrastis Canadensis 3X, Myrrha 3X, Phytolacca Decandra 3X, Trigonella Foenum Graecum 3X, Lymph (suis) 8X, Spleen (suis) 8X, Bryonia 12X, Bufo Rana 12X, Conium Maculatum 12X, Lac Caninum 12X, Lachesis Mutus 12X, Silicea 12X, Mammary Gland (human) 36C

INDICATIONS

For temporary relief of swollen or sensitive breasts.

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.

DIRECTIONS

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

INACTIVE INGREDIENTS

Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS AND USAGE

For temporary relief of swollen or sensitive breasts.

QUESTIONS

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

BioActive Homeopathic

MAMMARYPLEX

1 FL OZ (30 ml)

MAMMARYPLEX 
echinacea, hydrastis canadensis, myrrha, phytolacca decandra, trigonella foenum graecum, lymph, spleen, bryonia, bufo rana, conium maculatum, lac caninum, lachesis mutus, silicea, mammary gland, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0082
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	3 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	3 [hp_X]  in 1 mL
MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L)	MYRRH	3 [hp_X]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [hp_X]  in 1 mL
FENUGREEK SEED (UNII: 654825W09Z) (FENUGREEK SEED - UNII:654825W09Z)	FENUGREEK SEED	3 [hp_X]  in 1 mL
SUS SCROFA LYMPH (UNII: 33A7VYU29L) (SUS SCROFA LYMPH - UNII:33A7VYU29L)	SUS SCROFA LYMPH	8 [hp_X]  in 1 mL
SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y)	SUS SCROFA SPLEEN	8 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	12 [hp_X]  in 1 mL
BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q)	BUFO BUFO CUTANEOUS GLAND	12 [hp_X]  in 1 mL
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371)	CONIUM MACULATUM FLOWERING TOP	12 [hp_X]  in 1 mL
CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT)	CANIS LUPUS FAMILIARIS MILK	12 [hp_X]  in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	12 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 mL
HUMAN MAMMARY GLAND (UNII: C89WQP58WD) (HUMAN MAMMARY GLAND - UNII:C89WQP58WD)	HUMAN MAMMARY GLAND	36 [hp_C]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0082-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/13/2013	07/02/2019

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0082) , api manufacture(43857-0082) , label(43857-0082) , pack(43857-0082)

Revised: 5/2015

Document Id: 9d32d8f7-72a0-43e3-a955-31f40d2448ef

Set id: 6300bad7-b763-4ff1-983a-1eb668ab086b

Version: 2

Effective Time: 20150526