Label: FEMALE TONIC- condurango, humulus lupulus, agnus castus, caulophyllum thalictroides, iris versicolor, lilium tigrinum, asterias rubens, apis mellifica, calcarea fluorica, conium maculatum, ignatia amara, lac caninum, lachesis mutus, sepia cyclamen europaeum liquid

  • NDC Code(s): 43857-0333-1
  • 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 September 27, 2016

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  • ACTIVE INGREDIENTS:

    Condurango 1X, Humulus Lupulus 1X, Agnus Castus 3X, Caulophyllum Thalictroides 3X, Iris Versicolor 3X, Lilium Tigrinum 3X, Asterias Rubens 6X, 12X, Apis Mellifica 12X, Calcarea Fluorica 12X, Conium Maculatum 12X, Ignatia Amara 12X, Lac Caninum 12X, Lachesis Mutus 12X, Sepia 12X, Cyclamen Europaeum 15X.

  • INDICATIONS:

    For temporary relief of dysmenorrhea with severe ovarian pain; painful swollen breast before and during menses; menses early, profuse, black and clotted.

  • 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 dysmenorrhea with severe ovarian pain; painful swollen breast before and during menses; menses early, profuse, black and clotted.

  • 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

    FEMALE TONIC

    HOMEOPATHIC

    2 FL OZ (60 ml)

    Female Tonic

  • INGREDIENTS AND APPEARANCE
    FEMALE TONIC 
    condurango, humulus lupulus, agnus castus, caulophyllum thalictroides, iris versicolor, lilium tigrinum, asterias rubens, apis mellifica, calcarea fluorica, conium maculatum, ignatia amara, lac caninum, lachesis mutus, sepia cyclamen europaeum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MARSDENIA CONDURANGO BARK (UNII: R23QIR6YBA) (MARSDENIA CONDURANGO BARK - UNII:R23QIR6YBA) MARSDENIA CONDURANGO BARK1 [hp_X]  in 1 mL
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS1 [hp_X]  in 1 mL
    CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE3 [hp_X]  in 1 mL
    CAULOPHYLLUM THALICTROIDES ROOT (UNII: JTJ6HH6YEH) (CAULOPHYLLUM THALICTROIDES ROOT - UNII:JTJ6HH6YEH) CAULOPHYLLUM THALICTROIDES ROOT3 [hp_X]  in 1 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT3 [hp_X]  in 1 mL
    LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI) LILIUM LANCIFOLIUM WHOLE FLOWERING3 [hp_X]  in 1 mL
    ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS6 [hp_X]  in 1 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]  in 1 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP12 [hp_X]  in 1 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [hp_X]  in 1 mL
    CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT) CANIS LUPUS FAMILIARIS MILK12 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 mL
    CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0333-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/27/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/02/2014
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0333) , api manufacture(43857-0333) , label(43857-0333) , pack(43857-0333)
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