Label: HEADACHE COMPLEX- aconitum napellus, bryonia, cactus grandiflorus, chelidonium majus, cimicifuga racemosa, sanguinaria canadensis, spigelia anthelmia, thuja occidentails 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 June 1, 2011

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  • Purpose:

    Suggested use for one or more of the following symptoms:

    Stress headache, stiffness in the neck; pains behind eyes, in forehead and temples.

  • Usage and Dosage:

    For oral use only.

  • DOSAGE & ADMINISTRATION

    Adults:

        In Acute Phase:
                12-15 drops, every half hour until relief occurs
        When Relief Occurs:
                12-15 drops, 4-6 times per day

    Children 2-12 years:

                8-10 drops, 4-6 times per day

  • Warnings:

    Keep out of reach of children.

  • WARNINGS

    If symptoms persist, consult a physician.

    Do not use if ring on bottom of cap is broken or missing.

  • Active Ingredients:

    Aconitum napellus 12X, Bryonia 12X, Cactus grandiflorus 4X, Chelidonium majus 6X, Cimicifuga racemosa 6X, Sanguinaria canadensis 6X, Spigelia anthelmia 6X, Thuja occidentails 6X

  • Inactive Ingredients:

    Alcohol, 20% USP

  • QUESTIONS

    Manufactured by Nova Homeopathic Therapeutics Inc., Albuquerque, New Mexico USA 87109
    1-800-225-8094

  • PRINCIPAL DISPLAY PANEL

    Headache Complex Product


    Headache Complex Product

    Headache Complex Bottle Label


    Headache Complex Bottle

    Headache Complex Box


    Headache Complex Box


  • INGREDIENTS AND APPEARANCE
    HEADACHE COMPLEX 
    aconitum napellus, bryonia, cactus grandiflorus, chelidonium majus, cimicifuga racemosa, sanguinaria canadensis, spigelia anthelmia, thuja occidentails liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52731-7012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS12 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [hp_X]  in 1 mL
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM4 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS6 [hp_X]  in 1 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH6 [hp_X]  in 1 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT6 [hp_X]  in 1 mL
    SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA6 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52731-7012-21 in 1 BOX
    1NDC:52731-7012-150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2011
    Labeler - Nova Homeopathic Therapeutics, Inc. (194394540)
    Registrant - Nova Homeopathic Therapeutics, Inc. (194394540)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nova Homeopathic Therapeutics, Inc.194394540manufacture, label, pack
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