Label: ALLERGIES FORMULA- allium cepa, ambrosia artemisiaefolia, dulcamara, euphrasia officinalis, histaminum hydrochloricum, kali muriaticum, naphthalinum, natrum muriaticum 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 January 31, 2014

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  • ACTIVE INGREDIENT

    Drug Facts

    ____________________________________________________________________________________________________________________

    HPUS active ingredients: ​Allium cepa, Ambrosia artemisiaefolia, Dulcamara, Euphrasia officinalis, Histaminum hydrochloricum, Kali muriaticum, Naphthalinum, Natrum muriaticum. Equal volumes of each ingredient in a 10X potency.

  • INDICATIONS & USAGE

    Uses for temporary relief of allergy and hay fever symptoms: nasal and sinus congestion, runny nose, sneezing, cough, sore throat, red, itchy or watery eyes, bronchial irritation, postnasal drip.

  • INACTIVE INGREDIENT

    Inactive ingredients: Citric acid, potassium sorbate, purified water.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor, if symptoms persist or worsen.
    • If pregnant or breast-feeding, ask a healthcare professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions:

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Ages 12 and up: 3 sprays 3 times per day.
    • Ages 2-12: 2 sprays 3 times per day.
  • OTHER SAFETY INFORMATION

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

  • PURPOSE

    Uses for temporary relief of allergy and hay fever symptoms:

    • nasal and sinus congestion
    • runny nose
    • sneezing
    • cough
    • sore throat
    • red, itchy or watery eyes
    • bronchial irritation
    • postnasal drip
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGIES FORMULA 
    allium cepa, ambrosia artemisiaefolia, dulcamara, euphrasia officinalis, histaminum hydrochloricum, kali muriaticum, naphthalinum, natrum muriaticum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-1700
    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
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP10 [hp_X]  in 59 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA10 [hp_X]  in 59 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE10 [hp_X]  in 59 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE10 [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
    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:57955-1700-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/20/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(57955-1700)
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