Label: HEADACHE RELIEF- belladonna, bryonia, capsicum annuum, chininum arsenicosum, coffea cruda, gelsemium sempervirens, glonoinum, ignatia amara, kali bichromicum, lycopodium clavatum, natrum muriaticum, nux vomica, sanguinaria canadensis, spigelia anthelmia, sulphur. spray

  • 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 April 2, 2012

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  • Active Ingredients

    Official HPUS: Belladonna, Bryonia, Capsicum annuum, Chininum arsenicosum, Coffea cruda, Gelsemium sempervirens, Glonoinum, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia, Sulphur.

    Reference image headacherelief.jpg

  • Warnings

    If symptoms persist or worsen, consult a physician.  If pregnant or nursing, take only on advice of healthcare professional.  Keep out of reach of children.

    Other: Tamper resistant for your protection.  Use only if safety seal is intact.

    Reference image headacherelief.jpg

  • Purposes

    Uses for temporary relief of headache pain:

    • throbbing / splitting
    • tight / bursting
    • sinus / congestive
    • migraine / occipital
    • dull / sick
    • band feeling around head
    • morning headache
    • sun headache
    Reference image headacherelief.jpg
  • Indications and Usage

    Uses for temporary relief of headache pain: throbbing/splitting, tight/bursting, sinus/congestive, migraine/occipital, dull/sick, band feeling around head, morning headache, sun headache

    Reference image headacherelief.jpg

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Reference image headacherelief.jpg

  • Dosage and Administration

    Directions: Initially, depress pump until primed.  Hold close to mouth and spray directly into mouth.  Use 3 times daily.  Use additionally as needed.

    Adult Dose - 3 pump sprays

    Children (2-12 years) - 2 pump sprays

    Reference image headacherelief.jpg
  • Inactive Ingredients

    Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

    Reference image headacherelief.jpg

  • PRINCIPAL DISPLAY PANEL

    image of label

    King Bio, Inc.

    3 Westside Dr

    Asheville, NC 28806

    Questions? Call 800.543.3245

    www.kingbio.com




  • INGREDIENTS AND APPEARANCE
    HEADACHE RELIEF 
    belladonna, bryonia, capsicum annuum, chininum arsenicosum, coffea cruda, gelsemium sempervirens, glonoinum, ignatia amara, kali bichromicum, lycopodium clavatum, natrum muriaticum, nux vomica, sanguinaria canadensis, spigelia anthelmia, sulphur. spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-5153
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [hp_X]  in 59 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT10 [hp_X]  in 59 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM10 [hp_X]  in 59 mL
    QUININE ARSENITE (UNII: 42QO5P0NLM) (QUININE ARSENITE - UNII:42QO5P0NLM) QUININE ARSENITE10 [hp_X]  in 59 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN10 [hp_X]  in 59 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 59 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN10 [hp_X]  in 59 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [hp_X]  in 59 mL
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM DICHROMATE10 [hp_X]  in 59 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 59 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE10 [hp_X]  in 59 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 59 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT10 [hp_X]  in 59 mL
    SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-5153-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/08/2012
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture
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