PMS- angelica archangelica, cimicifuga racemosa, fucus vesiculosus, hypothalamus suis, magnesium gluconicum dihydricum, oophorinum (suis) pyridoxinum hydrochloricum, bovista, cuprum metallicum, sepia, zincum metallicum, lachesis mutus 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:

Angelica Archangelica 3X, Cimicifuga Racemosa 3X, Fucus Vesiculosus 3X, Hypothalamus Suis 6X, Magnesium Gluconicum Dihydricum 6X, Oophorinum (Suis) 6X, Pyridoxinum Hydrochloricum 6X, Bovista 12X, Cuprum Metallicum 12X, Sepia 12X, Zincum Metallicum 12X, Lachesis Mutus 15X.

INDICATIONS:

For temporary relief of fatigue, feelings or anxiety before menstruation, tender breasts, flushes of heat, and headaches.

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 fatigue, feelings or anxiety before menstruation, tender breasts, flushes of heat, and headaches.

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

PMS

HOMEOPATHIC

1 FL OZ (30 ml)

PMS

PMS
angelica archangelica, cimicifuga racemosa, fucus vesiculosus, hypothalamus suis, magnesium gluconicum dihydricum, oophorinum (suis) pyridoxinum hydrochloricum, bovista, cuprum metallicum, sepia, zincum metallicum, lachesis mutus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0314
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN) (ANGELICA ARCHANGELICA ROOT - UNII:DTN01M69SN)	ANGELICA ARCHANGELICA ROOT	3 [hp_X] in 1 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	3 [hp_X] in 1 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	3 [hp_X] in 1 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	6 [hp_X] in 1 mL
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM GLUCONATE	6 [hp_X] in 1 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	6 [hp_X] in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	6 [hp_X] in 1 mL
LYCOPERDON UTRIFORME FRUITING BODY (UNII: K2A74U428F) (LYCOPERDON UTRIFORME FRUITING BODY - UNII:K2A74U428F)	LYCOPERDON UTRIFORME FRUITING BODY	12 [hp_X] in 1 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	12 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X] in 1 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	12 [hp_X] in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	15 [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:43857-0314-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	07/14/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/14/2014

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0314) , api manufacture(43857-0314) , label(43857-0314) , pack(43857-0314)