Label: HEADACHE RELIEF- bryonia alba root - gelsemium sempervirens root - sanguinaria canadensis root - spigelia anthelmia - tablet, chewable

  • 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 November 14, 2012

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Belladonna 30C, HPUSRelieves throbbing pains
    Bryonia 30C, HPUSRelieves sharp pains
    Gelsemium sempervirens 30C, HPUSRelieves heaviness in the head
    Sanguinaria canadensis 30C, HPUSRelieves pain
    Spigelia anthelmia 30C, HPUSRelieves pain

    "HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.

    Statement of Identity: Analgesic.

  • PURPOSE

  • Uses

    For the relief of painful headaches and to help shorten the duration of the headache.

  • Warnings

    • Do not use if outer package seal is broken.
    • If headache persists for more than 36 hours consult a doctor. New onset of headaches could be an indication of a serious underlying illness.
    • Do not give to children under 8 years of age.
  • PREGNANCY OR BREAST FEEDING

    • If pregnant or breast-feeding, consult a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • Directions

    (adults and children 8 years of age and older)

    Chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow. Repeat every 4 hours as needed.

  • Other information

    • Safe to take with all other medications.
    • Store at 68-77°F (20-25°C) and keep out of direct sunlight.
    • Avoid humid or damp storage conditions. Close well when not in use.
  • Inactive Ingredients

    Lactose, magnesium stearate (vegetable source), stevia leaf extract.

  • DO NOT USE

  • Questions? Call toll free or email us at:

    1-888-60-B-WELL (1-888-602-9355)

    info@homeostasislabs.com

  • PRINCIPAL DISPLAY PANEL

    Box image
  • INGREDIENTS AND APPEARANCE
    HEADACHE RELIEF 
    bryonia alba root - gelsemium sempervirens root - sanguinaria canadensis root - spigelia anthelmia - tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47242-0081
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_C]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT30 [hp_C]
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT30 [hp_C]
    SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeDIAMOND (Rounded) Size11mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47242-0081-11 in 1 PACKAGE
    150 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Homeostasis Laboratories, Inc. (010569196)
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