Label: ALLERGY AND HAY FEVER RELIEF- allium cepa, ambrosia artemisiaefolia, arsenicum album, arum triphyllum, arundo mauritanica, euphrasia officinalis, lac defloratum, naphthalinum, natrum muriaticum, sabadilla, wyethia helenioides 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 September 7, 2016

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  • ACTIVE INGREDIENT

    HPUS Active Ingredients:​ Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Arum triphyllum, Arundo mauritanica, Euphrasia officinalis, Lac defloratum, Naphthalinum, Natrum muriaticum, Sabadilla, Wyethia helenioides. Equal volumes of each ingredient in 10X, 30X, 100X potencies.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Alcohol @ 20% (v/v), Glycerin @ 8% (v/v), in a pure water base.

  • INDICATIONS & USAGE

    Indications: For temporary relief of allergy and hay fever symptoms such as: sneezing, runny nose, watery, red or itchy eyes.

    Use according to label indications and/or standard homeopathic indications.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Hold close to mouth and spray 1 dose (3 complete pump sprays) directly in mouth 4-6 times daily until symptoms improve.
    • Before initial dose, depress pump 4-5 times or until primed.
    • Consult a physician for use in children under 12 years of age.
  • WARNINGS

    Warnings: If symptoms persist or get worse, consult a physician. If you are pregnant or nursing seek the advice of a physician before using this product. Keep this and all medications out of the reach of children. Do not use if bottle seal is broken or tampered with.

  • 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

    For temporary relief of allergy and hay fever symptoms such as:

    • sneezing
    • runny nose
    • watery, red or itchy eyes

    Use according to label indications and/or standard homeopathic indications.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGY AND HAY FEVER RELIEF 
    allium cepa, ambrosia artemisiaefolia, arsenicum album, arum triphyllum, arundo mauritanica, euphrasia officinalis, lac defloratum, naphthalinum, natrum muriaticum, sabadilla, wyethia helenioides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58066-7011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION10 [hp_X]  in 59.2 mL
    AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA10 [hp_X]  in 59.2 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE10 [hp_X]  in 59.2 mL
    ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM) ARISAEMA TRIPHYLLUM ROOT10 [hp_X]  in 59.2 mL
    ARUNDO PLINIANA ROOT (UNII: ZXE7LB03WC) (ARUNDO PLINIANA ROOT - UNII:ZXE7LB03WC) ARUNDO PLINIANA ROOT10 [hp_X]  in 59.2 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA10 [hp_X]  in 59.2 mL
    SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK10 [hp_X]  in 59.2 mL
    NAPHTHALENE (UNII: 2166IN72UN) (NAPHTHALENE - UNII:2166IN72UN) NAPHTHALENE10 [hp_X]  in 59.2 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE10 [hp_X]  in 59.2 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED10 [hp_X]  in 59.2 mL
    WYETHIA HELENIOIDES ROOT (UNII: J10PD1AQ0N) (WYETHIA HELENIOIDES ROOT - UNII:J10PD1AQ0N) WYETHIA HELENIOIDES ROOT10 [hp_X]  in 59.2 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58066-7011-759.2 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/02/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/02/2016
    Labeler - Beaumont Bio Med (070624288)
    Registrant - Beaumont Bio Med (070624288)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(58066-7011)
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