Label: PROGESTERONE liquid

  • NDC Code(s): 43857-0120-1
  • 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 May 2, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENTS:

    Progesterone 6X.

  • INDICATIONS:

    For temporary relief of aching legs, backache, mood swings, painful menses, painful breasts, headaches, hot flashes, and nervousness.

  • 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:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • 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 aching legs, backache, mood swings, painful menses, painful breasts, headaches, hot flashes, and nervousness.

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

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

    Progesterone 6X

  • INGREDIENTS AND APPEARANCE
    PROGESTERONE 
    progesterone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0120-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/09/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/09/2012
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0120) , api manufacture(43857-0120) , label(43857-0120) , pack(43857-0120)