Label: HEADACHE- belladonna, bryonia, gelsemium sempervirens, glonionum, melilotus officinalis, natrum muriaticum, nitricum acidum, nux vomica, silicea spigelia anthelmia 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 29, 2010

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    CONTENTS:  Belladonna 30X, Bryonia 30X, Gelsemium Sempervirens 30X, Glonoinum 30X, Melilotus Officinalis 30X, Natrum Muriaticum 30X, Nitricum Acidum 30X, Nux Vomica 30X, Silicea 30X, Spigelia Anthelmia 30X.


  • PURPOSE

    INDICATIONS:  For temporary relief of symptoms due to tension and pressure of the head, headache.

  • WARNINGS

    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 a cool, dry place.


  • DOSAGE & ADMINISTRATION

    SUGGESTED USE:  Adults and children 5 to 10 drops orally, 3 times daily or as directed by a health cars professional.  If symptoms persist, consult your health care professional.  Consult a physician for use in children under 12 years of age.


  • INACTIVE INGREDIENT

    OTHER INGREDIENTS:  Demineralized Water, 20% Ethanol

  • QUESTIONS

    Dist. By:

    Energique, Inc.

    201 Apple Blvd.

    Woodbine, IA  51579

    800-869-8078

  • PRINCIPAL DISPLAY PANEL

    ENERGIQUE

    HEADACHE HP

    HOMEOPATHIC REMEDY

    1 FL OZ (30 ML)

    Headache HP

  • INGREDIENTS AND APPEARANCE
    HEADACHE   HP
    belladonna, bryonia, gelsemium sempervirens, glonionum, melilotus officinalis, natrum muriaticum, nitricum acidum, nux vomica, silicea spigelia anthelmia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0305
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT30 [hp_X]  in 1 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN30 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE30 [hp_X]  in 1 mL
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID30 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 mL
    MELILOTUS OFFICINALIS POLLEN (UNII: UVC3Z60VTX) (MELILOTUS OFFICINALIS POLLEN - UNII:UVC3Z60VTX) MELILOTUS OFFICINALIS POLLEN30 [hp_X]  in 1 mL
    SPIGELIA (UNII: 467D26HS0B) (SPIGELIA - UNII:467D26HS0B) SPIGELIA30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0305-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/12/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture