Label: HEADACHE HP- silver nitrate, atropa belladonna, bryonia alba root, gelsemium sempervirens root, nitroglycerin, lachesis muta venom, lycopodium clavatum spore, melilotus officinalis top, sodium chloride, strychnos nux-vomica seed, silicon dioxide, 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 November 2, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*): Argentum Nitricum 30C, Belladonna 30C, Bryonia Alba 30C, Gelsemium Sempervirens 30C, Glonoinum 30C, Lachesis Mutus 30C, Lycopodium Clavatum 30C, Melilotus Officinalis 30C, Natrum Muriaticum 30C, Nux Vomica 30C, Silicea 30C, Spigelia Anthelmia 30C

  • INDICATIONS & USAGE

    USES: Temporarily relieves all types of headaches: bursting, throbbing, above the eye, congestive, &/or as if "band around th head or in a vice."

  • WARNINGS

    WARNING:

    Consult a physician for use in children under 12 years of age. IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

  • DO NOT USE

    OTHER INFORMATION: Tamper Seal: "Sealed for your protection."

    Do not use if seal is broken or missing.

  • REFERENCES

    *The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, USP Ethanol Alcohol 20%

  • QUESTIONS

    QUESTIONS AND COMMENTS?

    MFG FOR: Natural Creations / Woodbine, IA / 51579 712.647.1600

    LOT:

  • PURPOSE

    USES: Temporarily relieves all types of headaches: bursting, throbbing, above the eye, congestive, &/or as if "band around the head or in a vice."

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center.

  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0025-1

    HEADACHE HP

    Headaches

    HOMEOPATHIC

    UPC: 877730001535

    Image Of Label

  • INGREDIENTS AND APPEARANCE
    HEADACHE HP 
    silver nitrate, atropa belladonna, bryonia alba root, gelsemium sempervirens root, nitroglycerin, lachesis muta venom, lycopodium clavatum spore, melilotus officinalis top, sodium chloride, strychnos nux-vomica seed, silicon dioxide, spigelia anthelmia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0025
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER CATION30 [hp_C]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT30 [hp_C]  in 1 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN30 [hp_C]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM30 [hp_C]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
    MELILOTUS OFFICINALIS TOP (UNII: GM6P02J2DX) (MELILOTUS OFFICINALIS TOP - UNII:GM6P02J2DX) MELILOTUS OFFICINALIS TOP30 [hp_C]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) CHLORIDE ION30 [hp_C]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) COLLOIDAL SILICON DIOXIDE30 [hp_C]  in 1 mL
    SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0025-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/29/2007
    Labeler - Natural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc.030572478manufacture(43406-0025)
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