Label: SPLEEN (spleen- bovine liquid

  • NDC Code(s): 43857-0119-1
  • Packager: BioActive Nutritional, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 July 18, 2023

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  • 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.

  • 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:

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

  • INDICATIONS:

    For temporary relief of symptoms due to spleen dysregulation.

  • INACTIVE INGREDIENTS:

    Citric Acid, Demineralized Water, Ethanol 0.05%, Sodium Benzoate.

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional
    SPLEEN 6X
    HOMEOPATHIC
    1 FL OZ (30 ml)

    Spleen 6X

  • INGREDIENTS AND APPEARANCE
    SPLEEN 
    spleen (bovine) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0119
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3) BOS TAURUS SPLEEN6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0119-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/08/2012
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0119) , api manufacture(43857-0119) , label(43857-0119) , pack(43857-0119)
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