Label: BIOE HEADACHE- arsenic trioxide, atropa belladonna, actaea cimicifuga root, tubocurarine chloride, cyclamen purpurascens tuber, gelsemium sempervirens root, nitroglycerin, iris versicolor root, magnesium phosphate, dibasic trihydrate, anemone pulsatilla, toxicodendron radicans leaf, sanguinaria canadensis root, claviceps purpurea sclerotium, spigelia marilandica root liquid

  • 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 March 27, 2018

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  • Active Ingredients

    Arsenicum alb 12x, Belladonna 12x, Cimicifuga 6x, Curare 12x, Cyclamen 6x, Gelsemium 6x, Glonoin 9x, Iris versicolor 6x, Mag phos 12, Pulsatilla 6x, Rhus tox 6x, Sanguinaria 6x, Secale corn 6x, Spigelia 6x

    Purpose

  • Inactive ingredients:

    alcohol 20%, purified water.

  • INDICATIONS & USAGE

    For temporary relief of various types of headaches including migraine.

    These uses are based on traditional homeopathic practice. They have not been evauated by the FDA.

  • Dosage:

    In general, 10 drops under the tongue 3 times daily. In acute conditions, 10 drops every 15 minutes.  Children, one half the above dosage. For children 2 years and under, and for people nursing a baby or pregnant, seek the advice of a health professional before use.

  • WARNINGS

    DO NOT USE

    IF BioE IMPRINTED SEAL ON NECK IS BROKEN

    If symptoms worsen or persist for more than 7 days, consult a physician.

    Keep out of the reach of children.

  • Package Labeling:

    BioE Headache

  • INGREDIENTS AND APPEARANCE
    BIOE HEADACHE 
    arsenic trioxide, atropa belladonna, actaea cimicifuga root, tubocurarine chloride, cyclamen purpurascens tuber, gelsemium sempervirens root, nitroglycerin, iris versicolor root, magnesium phosphate, dibasic trihydrate, anemone pulsatilla, toxicodendron radicans leaf, sanguinaria canadensis root, claviceps purpurea sclerotium, spigelia marilandica root liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57293-4422
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 60 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 60 mL
    ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT) (ACTAEA CIMICIFUGA ROOT - UNII:65J267BAZT) ACTAEA CIMICIFUGA ROOT6 [hp_X]  in 60 mL
    TUBOCURARINE CHLORIDE (UNII: 900961Z8VR) (TUBOCURARINE - UNII:W9YXS298BM) TUBOCURARINE CHLORIDE12 [hp_X]  in 60 mL
    CYCLAMEN PURPURASCENS TUBER (UNII: G728143D8Q) (CYCLAMEN PURPURASCENS TUBER - UNII:G728143D8Q) CYCLAMEN PURPURASCENS TUBER6 [hp_X]  in 60 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT6 [hp_X]  in 60 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN9 [hp_X]  in 60 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [hp_X]  in 60 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE12 [hp_X]  in 60 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 60 mL
    TOXICODENDRON RADICANS LEAF (UNII: CDH3461U7L) (TOXICODENDRON RADICANS LEAF - UNII:CDH3461U7L) TOXICODENDRON RADICANS LEAF6 [hp_X]  in 60 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT6 [hp_X]  in 60 mL
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM6 [hp_X]  in 60 mL
    SPIGELIA MARILANDICA ROOT (UNII: 467D26HS0B) (SPIGELIA MARILANDICA ROOT - UNII:467D26HS0B) SPIGELIA MARILANDICA ROOT6 [hp_X]  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57293-4422-260 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/25/1991
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/25/1991
    Labeler - BioEnergetics, Inc. (102847014)
    Registrant - BioEnergetics, Inc. (102847014)
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