Label: MENOPAUSE- angelica archangelica, aralia quinquefolia, cimicifuga racemosa, hydrastis canadensis, pulsatilla, sabina, sepia, sulphuricum acidum, lachesis mutus liquid

  • NDC Code(s): 43857-0446-1
  • 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 May 22, 2017

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  • ACTIVE INGREDIENTS:

    Angelica Archangelica 3X, Aralia Quinquefolia 3X, Cimicifuga Racemosa 3X, Hydrastis Canadensis 3X, Pulsatilla 12X, Sabina 12X, Sepia 12X, Sulphuricum Acidum 12X, Lachesis Mutus 15X.

  • INDICATIONS:

    For temporary relief of flushes of heat with attacks of perspiration, physical weakness with headaches, moodiness with symptoms ever-changing.

  • 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:

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

  • INDICATIONS:

    For temporary relief of flushes of heat with attacks of perspiration, physical weakness with headaches, moodiness with symptoms ever-changing.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol.

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    MENOPAUSE

    1 FL OZ (30 ml)

    Menopause

  • INGREDIENTS AND APPEARANCE
    MENOPAUSE 
    angelica archangelica, aralia quinquefolia, cimicifuga racemosa, hydrastis canadensis, pulsatilla, sabina, sepia, sulphuricum acidum, lachesis mutus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0446
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN) (ANGELICA ARCHANGELICA ROOT - UNII:DTN01M69SN) ANGELICA ARCHANGELICA ROOT3 [hp_X]  in 1 mL
    AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG3 [hp_X]  in 1 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA12 [hp_X]  in 1 mL
    JUNIPERUS SABINA LEAFY TWIG (UNII: Z5BEX9K2G1) (JUNIPERUS SABINA LEAFY TWIG - UNII:Z5BEX9K2G1) JUNIPERUS SABINA LEAFY TWIG12 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID12 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0446-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/18/2017
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0446) , api manufacture(43857-0446) , label(43857-0446) , pack(43857-0446)
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