Label: IMMUNE FORTE (dehydroepiandrosterone (dhea), estradiol, hypophysis suis, pregnenolone, progesterone, spleen (bovine), testosterone, thymus (suis), thyroidinum- suis liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CIII
  • 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 January 21, 2022

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  • ACTIVE INGREDIENTS:

    Dehydroepiandrosterone (DHEA) 8X, Estradiol 8X, Hypophysis Suis 8X, Pregnenolone 8X, Progesterone 8X, Spleen (Bovine) 8X, Testosterone 8X,  Thymus (Suis) 8X, Thyroidinum (Suis) 8X, 12X.

  • INDICATIONS:

    For temporary relief of weakness after flu or viral infection, for fortifying spleen and thymus and general revitalization.

  • 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 a 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 weakness after flu or viral infection, for fortifying spleen and thymus and general revitalization.

  • INACTIVE INGREDIENTS:

    Citric Acid, Demineralized Water, Ethanol 0.095%, Glycerin, Sodium Benzoate.

  • QUESTIONS:

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

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    IMMUNE FORTE

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Immune Forte

  • INGREDIENTS AND APPEARANCE
    IMMUNE FORTE 
    dehydroepiandrosterone (dhea), estradiol, hypophysis suis, pregnenolone, progesterone, spleen (bovine), testosterone, thymus (suis), thyroidinum (suis) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0166
    Route of AdministrationORALDEA ScheduleCIII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B) PRASTERONE8 [hp_X]  in 1 mL
    ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL8 [hp_X]  in 1 mL
    SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT) SUS SCROFA PITUITARY GLAND8 [hp_X]  in 1 mL
    PREGNENOLONE (UNII: 73R90F7MQ8) (PREGNENOLONE - UNII:73R90F7MQ8) PREGNENOLONE8 [hp_X]  in 1 mL
    PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE8 [hp_X]  in 1 mL
    BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3) BOS TAURUS SPLEEN8 [hp_X]  in 1 mL
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE8 [hp_X]  in 1 mL
    SUS SCROFA THYMUS (UNII: 7B69B0BD62) (SUS SCROFA THYMUS - UNII:7B69B0BD62) SUS SCROFA THYMUS8 [hp_X]  in 1 mL
    THYROID, PORCINE (UNII: 6RV024OAUQ) (SUS SCROFA THYROID - UNII:6RV024OAUQ) THYROID, PORCINE8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0166-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/02/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/07/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0166) , api manufacture(43857-0166) , label(43857-0166) , pack(43857-0166)
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