ENDOPLEX F- cimicifuga racemosa, fucus vesiculosus, glycyrrhiza glabra, xanthoxylum fraxineum, adrenalinum, cerebrum suis, hypophysis suis, hypothalamus (suis), oophorinum (suis), pineal (suis), thyroidinum (suis), pulsatilla (vulgaris), 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:

Cimicifuga Racemosa 3X, Fucus Vesiculosus 3X, Glycyrrhiza Glabra 3X, Xanthoxylum Fraxineum 3X, Adrenalinum 8X, Cerebrum Suis 8X, Hypophysis Suis 8X, Hypothalamus (Suis) 8X, Oophorinum (Suis) 8X, Pineal (Suis) 8X, Thyroidinum (Suis) 8X, Pulsatilla (Vulgaris) 12X, Sepia 12X.

INDICATIONS:

For temporary relief of menstrual pain and cramps, pain immediately prior to menses, and sore tender breasts associated with menstruation.

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 menstrual pain and cramps, pain immediately prior to menses, and sore tender breasts associated with menstruation.

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

ENDOPLEX F

HOMEOPATHIC

1 FL OZ (30 ml)

Endoplex F

ENDOPLEX F
cimicifuga racemosa, fucus vesiculosus, glycyrrhiza glabra, xanthoxylum fraxineum, adrenalinum, cerebrum suis, hypophysis suis, hypothalamus (suis), oophorinum (suis), pineal (suis), thyroidinum (suis), pulsatilla (vulgaris), sepia liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0417
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H)	GLYCYRRHIZA GLABRA	3 [hp_X] in 1 mL
ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T)	ZANTHOXYLUM AMERICANUM BARK	3 [hp_X] in 1 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	8 [hp_X] in 1 mL
SUS SCROFA CEREBRUM (UNII: 4GB5DQR532) (SUS SCROFA CEREBRUM - UNII:4GB5DQR532)	SUS SCROFA CEREBRUM	8 [hp_X] in 1 mL
SUS SCROFA PITUITARY GLAND (UNII: E8S87O660T) (SUS SCROFA PITUITARY GLAND - UNII:E8S87O660T)	SUS SCROFA PITUITARY GLAND	8 [hp_X] in 1 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	8 [hp_X] in 1 mL
SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O)	SUS SCROFA OVARY	8 [hp_X] in 1 mL
SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7)	SUS SCROFA PINEAL GLAND	8 [hp_X] in 1 mL
SUS SCROFA THYROID (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ)	SUS SCROFA THYROID	8 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	PULSATILLA VULGARIS	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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0417-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/29/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/29/2016

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0417) , api manufacture(43857-0417) , label(43857-0417) , pack(43857-0417)