MAMMARYPLEX- echinacea (angustifolia), myrrha, trigonella foenum-graecum, phytolacca decandra, hydrastis canadensis, lymph (suis), spleen (suis), bryonia (alba), conium maculatum, lac caninum, lachesis mutus, silicea, bufo rana, mammary gland (bovine) 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 (Angustifolia) 3X, Myrrha 3X, Trigonella Foenum-Graecum 3X, Phytolacca Decandra 4X, Hydrastis Canadensis 5X, Lymph (Suis) 8X, Spleen (Suis) 8X, Bryonia 12X, Conium Maculatum 12X, Lac Caninum 12X, Lachesis Mutus 12X, Silicea 12X, Bufo Rana 14X, 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.

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 swollen or sensitive breasts.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

MAMMARYPLEX

HOMEOPATHIC

1 FL OZ (30 ml)

Mammaryplex

MAMMARYPLEX
echinacea (angustifolia), myrrha, trigonella foenum-graecum, phytolacca decandra, hydrastis canadensis, lymph (suis), spleen (suis), bryonia (alba), conium maculatum, lac caninum, lachesis mutus, silicea, bufo rana, mammary gland (bovine) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0498
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	3 [hp_X] in 1 mL
MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L)	MYRRH	3 [hp_X] in 1 mL
FENUGREEK SEED (UNII: 654825W09Z) (FENUGREEK SEED - UNII:654825W09Z)	FENUGREEK SEED	3 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	4 [hp_X] in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	5 [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
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) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X] in 1 mL
BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q)	BUFO BUFO CUTANEOUS GLAND	14 [hp_X] in 1 mL
BOS TAURUS MAMMARY GLAND (UNII: 714I8DV77O) (BOS TAURUS MAMMARY GLAND - UNII:714I8DV77O)	BOS TAURUS MAMMARY GLAND	36 [hp_C] 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:43857-0498-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/11/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/11/2018

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0498) , api manufacture(43857-0498) , label(43857-0498) , pack(43857-0498)