Label: HEADACHE- belladonna, cimicifuga racemosa, glonoinum, lachesis mutus, zingiber officinale, 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 August 3, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Belladonna 10X, Cimicifuga racemosa 10X, Glonoinum 10X, Lachesis mutus 10X, Zingiber officinale 10X.

  • PURPOSE

    INDICATIONS:  For temporary relief of symptoms related to headaches.

  • WARNINGS

    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 a cool, dry place.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  10 drops orally, 1-2 times a day or as directed by a health care professional.  Consult a physician for use in children under 12 years of age.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.

  • QUESTIONS


    Manufactured for and Distributed by:

    Becker Health Solutions

    12940 Prosperity Ave.

    P.O. Box 443

    Becker, MN 55308

  • PRINCIPAL DISPLAY PANEL

    Becker

    Health Solutions

    HEADACHE

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Headache

  • INGREDIENTS AND APPEARANCE
    HEADACHE 
    belladonna, cimicifuga racemosa, glonoinum, lachesis mutus, zingiber officinale, liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0231
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [hp_X]  in 1 mL
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH10 [hp_X]  in 1 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN10 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM10 [hp_X]  in 1 mL
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER10 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0231-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/03/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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