Label: ALLERGY AND HAY FEVER- allium cepa, ambrosia artemisiaefolia, arsenicum album, arum triphyllum, arundo mauritanica, euphrasia officinalis, 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 August 11, 2014

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  • ACTIVE INGREDIENT

    Active Ingredients: (Official HPUS) Allium cepa, Ambrosia artemisiaefolia, Arsenicum album, Arum triphyllum, Arundo mauritanica, Euphrasia officinalis, Naphthalinum, Natrum muriaticum, Sabadilla, Wyethia helenioides. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric acid, potassium sorbate, pure water base.

  • INDICATIONS & USAGE

    Uses: For the temporary relief of allergy and hay fever symptoms due to seasonal allergies, rhinitus, sinus congestion and pain, itchy, red and watery eyes, sneezing, runny nose, postnasal drip, cough and sore throat. Will not cause drowsiness.

  • DOSAGE & ADMINISTRATION

    Directions: Spray directly into mouth. Adult dose- 3 pump sprays 3 times daily. Children's Dose, (ages 2-12) 3 pump sprays, 3 times daily. Use additionally as needed.

  • WARNINGS

    Warnings: If symptoms persist or worsen, stop usage and consult a physician. If pregnant or breast-feeding, take only upon advice of a healthcare professional.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • OTHER SAFETY INFORMATION

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

  • PURPOSE

    Uses: For the temporary relief of allergy and hay fever symptoms due to

    • seasonal allergies
    • rhinitus
    • sinus congestion and pain
    • itchy, red and watery eyes
    • sneezing
    • runny nose
    • postnasal drip
    • cough
    • sore throat

    Will not cause drowsiness.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGY AND HAY FEVER 
    allium cepa, ambrosia artemisiaefolia, arsenicum album, arum triphyllum, arundo mauritanica, euphrasia officinalis, naphthalinum, natrum muriaticum, sabadilla, wyethia helenioides liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50441-0002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION10 [hp_X]  in 59 mL
    AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA10 [hp_X]  in 59 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE10 [hp_X]  in 59 mL
    ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM) ARISAEMA TRIPHYLLUM ROOT10 [hp_X]  in 59 mL
    ARUNDO PLINIANA ROOT (UNII: ZXE7LB03WC) (ARUNDO PLINIANA ROOT - UNII:ZXE7LB03WC) ARUNDO PLINIANA ROOT10 [hp_X]  in 59 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA10 [hp_X]  in 59 mL
    NAPHTHALENE (UNII: 2166IN72UN) (NAPHTHALENE - UNII:2166IN72UN) NAPHTHALENE10 [hp_X]  in 59 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE10 [hp_X]  in 59 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED10 [hp_X]  in 59 mL
    WYETHIA HELENIOIDES ROOT (UNII: J10PD1AQ0N) (WYETHIA HELENIOIDES ROOT - UNII:J10PD1AQ0N) WYETHIA HELENIOIDES ROOT10 [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:50441-0002-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/08/2012
    Labeler - PharmWest Inc. (010587579)
    Registrant - PharmWest Inc. (010587579)
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