Label: DHEA FORTE (dehydroepiandrosterone- dhea, pregnenolone, progesterone, liquid

  • NDC Code(s): 43857-0052-1
  • Packager: BioActive Nutritionals, 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 June 15, 2016

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

  • ACTIVE INGREDIENTS:

    Dehydroepiandrosterone (DHEA) 6X, Pregnenolone 6X, Progesterone 6X.

  • INDICATIONS:

    For temporary relief of stressful situations, lowered immune response, inflammation processes, enhances calcium metabolism in bones, improves moods, and enhances cell metabolism.

  • 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.

  • 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:

    One spray three times per day. Hold in mouth for two minutes.

  • INDICATIONS:

    For temporary relief of stressful situations, lowered immune response, inflammation processes, enhances calcium metabolism in bones, improves moods, and enhances cell metabolism.

  • INACTIVE INGREDIENTS:

    Citric Acid, Demineralized Water, Glycerin, Sodium Benzoate

  • QUESTIONS:

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

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    DHEA FORTE

    HOMEOPATHIC

    1 FL OZ (30 ml)

    DHEA Forte

  • INGREDIENTS AND APPEARANCE
    DHEA FORTE 
    dehydroepiandrosterone (dhea), pregnenolone, progesterone, liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0052
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B) PRASTERONE6 [hp_X]  in 1 mL
    PREGNENOLONE (UNII: 73R90F7MQ8) (PREGNENOLONE - UNII:73R90F7MQ8) PREGNENOLONE6 [hp_X]  in 1 mL
    PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0052-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/07/2012
    Labeler - BioActive Nutritionals, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0052) , api manufacture(43857-0052) , label(43857-0052) , pack(43857-0052)