SPLEEN- spleen (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:

Spleen (Bovine) 6X.

INDICATIONS:

For temporary relief of symptoms due to spleen dysregulation.

WARNINGS:

If pregnant or breast-feeding, ask a health 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:

Three sprays per day. Hold in mouth for two minutes.

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 symptoms due to spleen dysregulation.

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 Nutritional

SPLEEN 6X

HOMEOPATHIC

1 FL OZ (30 ml)

Spleen 6X

SPLEEN 
spleen (bovine) liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0119
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3) BOS TAURUS SPLEEN 6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43857-0119-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/06/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/08/2012
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
Name Address ID/FEI Business Operations
Apotheca Company 844330915 manufacture(43857-0119) , api manufacture(43857-0119) , label(43857-0119) , pack(43857-0119)

Revised: 4/2016
Document Id: 19a44ab3-df03-4305-a5e4-ec5a07757fe4
Set id: cb56c58f-2f2f-4803-8659-9a34681a9b8e
Version: 2
Effective Time: 20160406
 
BioActive Nutritional, Inc.