MAMMARYPLEX- echinacea (angustifolia), hydrastis canadensis, myrrha, phytolacca decandra, trigonella foenum-graecum, lymph (suis

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8), GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV), MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L), PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG), FENUGREEK SEED (UNII: 654825W09Z) (FENUGREEK SEED - UNII:654825W09Z), SUS SCROFA LYMPH (UNII: 33A7VYU29L) (SUS SCROFA LYMPH - UNII:33A7VYU29L), SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y),
Available from:
BioActive Nutritional, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of swollen or sensitive breasts. For temporary relief of swollen or sensitive breasts.
Authorization status:
unapproved homeopathic
Authorization number:
43857-0348-1

MAMMARYPLEX- echinacea (angustifolia), hydrastis canadensis, myrrha, phytolacca

decandra, trigonella foenum-graecum, lymph (suis), spleen (suis), bryonia (alba), bufo rana,

conium maculatum, lac caninum, lachesis mutus, silicea, mammary gland (human) 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.

----------

DRUG FACTS:

ACTIVE INGREDIENTS:

Echinacea (Angustifolia) 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.

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

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

BioActive Homeopathic

MAMMARYPLEX

1 FL OZ (30 ml)

MAMMARYPLEX

echinacea (angustifolia), hydrastis canadensis, myrrha, phytolacca decandra, trigonella foenum-graecum, lymph

(suis), spleen (suis), bryonia (alba), bufo rana, conium maculatum, lac caninum, lachesis mutus, silicea, mammary

gland (human) liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:438 57-0 348

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ECHINACEA ANGUSTIFO LIA (UNII: VB0 6 AV5US8 ) (ECHINACEA ANGUSTIFOLIA -

UNII:VB0 6 AV5US8 )

ECHINACEA

ANGUSTIFOLIA

3 [hp_X]

in 1 mL

GO LDENSEAL (UNII: ZW3Z11D0 JV) (GOLDENSEAL - UNII:ZW3Z11D0 JV)

GOLDENSEAL

3 [hp_X]

in 1 mL

MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L)

MYRRH

3 [hp_X]

in 1 mL

PHYTO LACCA AMERICANA RO O T (UNII: 11E6 VI8 VEG) (PHYTOLACCA AMERICANA

ROOT - UNII:11E6 VI8 VEG)

PHYTOLACCA AMERICANA

ROOT

3 [hp_X]

in 1 mL

FENUGREEK SEED (UNII: 6 548 25W0 9 Z) (FENUGREEK SEED - UNII:6 548 25W0 9 Z)

FENUGREEK SEED

3 [hp_X]

in 1 mL

SUS SCRO FA LYMPH (UNII: 33A7VYU29 L) (SUS SCROFA LYMPH - UNII:33A7VYU29 L)

SUS SCROFA LYMPH

8 [hp_X]

in 1 mL

SUS SCRO FA SPLEEN (UNII: 9 2AMN5J79 Y) (SUS SCROFA SPLEEN -

UNII:9 2AMN5J79 Y)

SUS SCROFA SPLEEN

8 [hp_X]

in 1 mL

BRYO NIA ALBA RO O T (UNII: T7J0 46 YI2B) (BRYONIA ALBA ROOT -

UNII:T7J0 46 YI2B)

BRYONIA ALBA ROOT

12 [hp_X]

in 1 mL

BUFO BUFO CUTANEO US GLAND (UNII: Q59 QU6 N72Q) (BUFO BUFO CUTANEOUS

GLAND - UNII:Q59 QU6 N72Q)

BUFO BUFO CUTANEOUS

GLAND

12 [hp_X]

in 1 mL

CO NIUM MACULATUM FLO WERING TO P (UNII: Q28 R5GF371) (CONIUM

MACULATUM FLOWERING TOP - UNII:Q28 R5GF371)

CONIUM MACULATUM

FLOWERING TOP

12 [hp_X]

in 1 mL

CANIS LUPUS FAMILIARIS MILK (UNII: G39 P120 JQT) (CANIS LUPUS FAMILIARIS

MILK - UNII:G39 P120 JQT)

CANIS LUPUS FAMILIARIS

MILK

12 [hp_X]

in 1 mL

LACHESIS MUTA VENO M (UNII: VSW71SS0 7I) (LACHESIS MUTA VENOM -

UNII:VSW71SS0 7I)

LACHESIS MUTA VENOM

12 [hp_X]

in 1 mL

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6 XBU4)

SILICON DIOXIDE

12 [hp_X]

in 1 mL

HUMAN MAMMARY GLAND (UNII: C8 9 WQP58 WD) (HUMAN MAMMARY GLAND -

UNII:C8 9 WQP58 WD)

HUMAN MAMMARY GLAND

36 [hp_C]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:438 57-

0 348 -1

30 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 1/20 14

12/0 4/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

12/0 1/20 14

12/0 4/20 19

Labeler -

BioActive Nutritional, Inc. (624980496)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(438 57-0 348 ) , api manufacture(438 57-0 348 ) , label(438 57-0 348 ) , pack(438 57-

0 348 )

BioActive Nutritional, Inc.

Revised: 1/2017

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