Label: HEADEK NASAL- belladonna, glonoinum, coffea, natrum carb, natrum mur. spray

  • NDC Code(s): 66492-005-02
  • Packager: Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics
  • 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 29, 2021

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (HPUS*): Belladonna 3X, 12X. Glonoinum 6X, 12X. Coffea 6X. Natrum Carb 6X. Natrum Mur 12X. (Relieves Headache & Migraine)

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

  • INDICATIONS & USAGE

    ​INDICATIONS: Temporarily relieves headaches and migraines. ​

  • WARNINGS

    WARNINGS: If symptoms persist or worsen, a health professional should be consulted. As with any drug, if you are pregnant or nursing seek the advice of your physician before using this product. Consult a physician for use in children under 12 years of age.

    Keep this and all medicines out of the reach of children.

  • DOSAGE & ADMINISTRATION

    ​DOSAGE:​ Adults and children above 12 years: 1 spray in each nostril three to eight times daily. Consult a health care professional for use in children under 12 years of age.

  • OTHER SAFETY INFORMATION

    TAMPER EVIDENT: There is a safety seal on the neck and cap of the bottle. Do not use this product if the safety seal is broken or missing.

  • INACTIVE INGREDIENT

    ​INACTIVE INGREDIENTS: ​Demineralized Water, Sodium Chloride, Benzalkonium Chloride.

  • QUESTIONS

    Manufactured for: Be Well Homeopathics Inc. Miami, FL 33178 • 1-877-438-3042

    www.bewellhomeo.com

  • PRINCIPAL DISPLAY PANEL

    NDC 66492-005-02

    Be Well Homeopathics

    HEADEK NASAL SPRAY

    30ml

    1oz bottle label

    Headache/Migraines

  • INGREDIENTS AND APPEARANCE
    HEADEK NASAL 
    belladonna, glonoinum, coffea, natrum carb, natrum mur. spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66492-005
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_X]  in 30 mL
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN6 [hp_X]  in 30 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 30 mL
    SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE6 [hp_X]  in 30 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE12 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66492-005-0230 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/22/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/22/2011
    Labeler - Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics (052584997)
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