PROGESTERONE- progesterone 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:

Progesterone 6X, 12X, 30X, 12C, 30C.

INDICATIONS:

For temporary relief of aching legs, backache, mood swings, painful menses, painful breasts, headaches, hot flashes, and nervousness.

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:

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

INDICATIONS:

For temporary relief of aching legs, backache, mood swings, painful menses, painful breasts, headaches, hot flashes, and nervousness.

QUESTIONS:

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

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

PROGESTERONE

HOMEOPATHIC

1 FL OZ (30 ML)

Progesterone

PROGESTERONE 
progesterone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0103-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/14/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/12/2013
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0103) , api manufacture(43857-0103) , label(43857-0103) , pack(43857-0103)

Revised: 4/2016
Document Id: 0fbb882f-ea06-4d40-be08-8fef05705c57
Set id: 0de91238-dacc-4a5c-86d8-ad94024b2c95
Version: 2
Effective Time: 20160414
 
BioActive Nutritional, Inc.