Label: MIDWEST REGIONAL ALLERGIES- adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, cichorium intybus, conium maculatum, cortisone aceticum, euphrasia officinalis, fagopyrum esculentum, galphimia glauca, hedera helix, histaminum hydrochloricum, kali muriaticum, mucosa nasalis suis, natrum muriaticum, rna, rumex crispus, sabadilla, secale cornutum 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 November 4, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts

    ____________________________________________________________________________________________________________

    Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

    HPUS active ingredients: Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Cichorium intybus, Conium maculatum, Cortisone aceticum, Euphrasia officinalis, Fagopyrum esculentum, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, RNA, Rumex crispus, Sabadilla, Secale cornutum.

  • INDICATIONS & USAGE

    Uses for temporary relief of allergy symptoms commonly experienced in IA, IL, IN, KS, MI, MN, MO, ND, NE, OH, SD, WI:

    • itchy, watery eyes
    • runny nose
    • sneezing
    • sore throat
    • sinus congestion
    • cough
    • stuffy nose
    • fatigue
    • itchy, irritated skin
    • hoarseness
    • headache
  • WARNINGS

    Warnings

    • Stop use and ask a 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.
    • Adults: 3 sprays 3 times per day.
    • Children ages 6-12: 2 sprays 3 times per day.
    • Use additionally as needed, up to 6 times per day.
  • OTHER SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

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

  • PURPOSE

    Drug Facts

    __________________________________________________________________________________________________________________

    HPUS active ingredients                                                                    Purpose

    Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

    Adenosinum cyclophosphoricum............................................headache, runny nose

    Adrenalinum.......................................................................hay fever, swollen sinuses, lung congestion

    Adrenocorticotrophin............................................................inflammation, congestion, cough

    Allium cepa.........................................................................hay fever, sinus headache, sneezing

    Ambrosia artemisiaefolia.......................................................hay fever, cough

    Cichorium intybus................................................................fatigue, headache, eye irritation

    Conium maculatum..............................................................sick headache, shortness of breath

    Cortisone aceticum...............................................................minor allergic reaction, irritability

    Euphrasia officinalis..............................................................discharge from the eyes and nose

    Fagopyrum esculentum.........................................................red, itching eyes, headache

    Galphimia glauca..................................................................swollen eyelids, hay fever

    Hedera helix........................................................................catarrhal inflammation, cough with sputum

    Histaminum hydrochloricum...................................................coughing, itching throat

    Kali muriaticum....................................................................hoarseness, stuffy nose

    Mucosa nasalis suis...............................................................sinus headache, nasal congestion

    Natrum muriaticum...............................................................watery eyes, sneezing

    RNA....................................................................................minor allergic reactions

    Rumex crispus......................................................................raw throat with much mucus, dry cough

    Sabadilla..............................................................................sore throat, runny nose, sneezing

    Secale cornutum...................................................................minor difficulty breathing

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MIDWEST REGIONAL ALLERGIES 
    adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, cichorium intybus, conium maculatum, cortisone aceticum, euphrasia officinalis, fagopyrum esculentum, galphimia glauca, hedera helix, histaminum hydrochloricum, kali muriaticum, mucosa nasalis suis, natrum muriaticum, rna, rumex crispus, sabadilla, secale cornutum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-8315
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) (ADENOSINE CYCLIC 3',5'-PHOSPHATE - UNII:E0399OZS9N) ADENOSINE CYCLIC PHOSPHATE10 [hp_X]  in 29.6 mL
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE10 [hp_X]  in 29.6 mL
    CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA) CORTICOTROPIN10 [hp_X]  in 29.6 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION10 [hp_X]  in 29.6 mL
    AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA10 [hp_X]  in 29.6 mL
    CHICORY ROOT (UNII: 090CTY533N) (CHICORY ROOT - UNII:090CTY533N) CHICORY ROOT10 [hp_X]  in 29.6 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP10 [hp_X]  in 29.6 mL
    CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE10 [hp_X]  in 29.6 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA10 [hp_X]  in 29.6 mL
    FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM10 [hp_X]  in 29.6 mL
    GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP10 [hp_X]  in 29.6 mL
    HEDERA HELIX FLOWERING TWIG (UNII: 3D10KUA6BM) (HEDERA HELIX FLOWERING TWIG - UNII:3D10KUA6BM) HEDERA HELIX FLOWERING TWIG10 [hp_X]  in 29.6 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE10 [hp_X]  in 29.6 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE10 [hp_X]  in 29.6 mL
    SUS SCROFA NASAL MUCOSA (UNII: ID3Z1X61WY) (SUS SCROFA NASAL MUCOSA - UNII:ID3Z1X61WY) SUS SCROFA NASAL MUCOSA10 [hp_X]  in 29.6 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE10 [hp_X]  in 29.6 mL
    SACCHAROMYCES CEREVISIAE RNA (UNII: J17GBZ5VGX) (SACCHAROMYCES CEREVISIAE RNA - UNII:J17GBZ5VGX) SACCHAROMYCES CEREVISIAE RNA10 [hp_X]  in 29.6 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT10 [hp_X]  in 29.6 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED10 [hp_X]  in 29.6 mL
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM10 [hp_X]  in 29.6 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:57955-8315-11 in 1 CARTON
    129.6 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/04/2013
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(57955-8315)