Label: HEADACHE RELIEF II- gelsemium sempervirens, glonoinum, iris versicolor, kali carbonicum, lycopodium clavatum, natrum muriaticum, niccolum metallicum, nux vomica, sanguinaria canadensis, secale cornutum, spigelia anthelmia, sulphur 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 October 24, 2014

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  • DOSAGE & ADMINISTRATION

    Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

    Adult Dose: 3 Pump Sprays

    Child's Dose (2-12): 2 Pump Sprays

    Infants - 2 yrs. 1 Pump Spray

  • WARNINGS

    Warnings: If symptoms persist or worsen, seek advice of a physician. If pregnant or breast-feeding, take only on advice of physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

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

  • PURPOSE

    Indications: For temporary relief of symptoms from the following headaches: •migraine •sick •throbbing •occipital •morning •sun

  • ACTIVE INGREDIENT

    Active Ingredients: Gelsemium sempervirens, Glonoinum, Iris versicolor, Kali carbonicum, Lycopodium clavatum, Natrum muriaticum, Niccolum metallicum, Nux vomica, Sanguinaria canadensis, Secale cornutum, Spigelia anthelmia, Sulphur​. ​Equal volumes of each ingredient in 10X, 30X, and 100X potencies.

  • INACTIVE INGREDIENT

    Inactive Ingredient: Citric acid, potassium sorbate, purified water.

  • INDICATIONS & USAGE

    Indications: For temporary relief of symptoms from the following headaches:

    • migraine
    • sick
    • throbbing
    • occipital
    • morning 
    • sun
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HEADACHE RELIEF II 
    gelsemium sempervirens, glonoinum, iris versicolor, kali carbonicum, lycopodium clavatum, natrum muriaticum, niccolum metallicum, nux vomica, sanguinaria canadensis, secale cornutum, spigelia anthelmia, sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66579-0060
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT10 [hp_X]  in 59 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE10 [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) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE10 [hp_X]  in 59 mL
    NICKEL (UNII: 7OV03QG267) (NICKEL - UNII:7OV03QG267) NICKEL10 [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
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM10 [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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66579-0060-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/28/2011
    Labeler - New Sun Inc. (957251176)
    Registrant - New Sun Inc. (957251176)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(66579-0060)
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