Label: SPLEEN- spleen (bovine) liquid

  • NDC Code(s): 43857-0119-1
  • Packager: BioActive Nutritional, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 Label Information

Updated April 6, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Spleen (Bovine) 6X.

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  • INDICATIONS:

    For temporary relief of symptoms due to spleen dysregulation.

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  • 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.

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  • DIRECTIONS:

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

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  • INACTIVE INGREDIENTS:

    Demineralized water, 25% Ethanol.

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  • 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.

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  • INDICATIONS:

    For temporary relief of symptoms due to spleen dysregulation.

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  • QUESTIONS:

    Distributed by:

    BIOACTIVE NUTRITIONAL

    Melbourne, FL 32935

    For Nutritional Information write:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

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  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    SPLEEN 6X

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Spleen 6X

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  • INGREDIENTS AND APPEARANCE
    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)
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