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

  • NDC Code(s): 43406-0025-1
  • Packager: Natural Creations, Inc.
  • 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 December 27, 2022

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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 symptoms due to tension and pressure of the head, headache.**

  • 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.
    • DO not use if TAMPER EVIDENT seal is broken or missing.
  • DOSAGE & ADMINISTRATION

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

  • REFERENCES

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

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Purified Water, USP Ethyl Alcohol

  • QUESTIONS

    QUESTIONS AND COMMENTS?

    Natural Creations / Woodbine, IA / 51579 / 712-647-1600

  • PURPOSE

    USES: Temporarily relieves symptoms due to tension and pressure of the head, headache.**

  • 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

    HOMEOPATHIC

    1 fl oz (30mL) / 20% Alcohol

    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 NITRATE30 [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) SODIUM CHLORIDE30 [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) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) 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; Type 0: Not a Combination Product05/29/2007
    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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