Label: REGIONAL ALLERGIES GREAT LAKES U.S.- adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, arum triphyllum, arundo mauritanica, chelidonium majus, chenopodium vulvaria, cichorium intybus, cortisone aceticum, euphrasia officinalis, galphimia glauca, hedera helix, histaminum hydrochloricum, juglans cinerea, kali muriaticum, natrum muriaticum, pulsatilla, rna, sabadilla, teucrium scorodonia. 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, 2022

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

  • 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.


    Consult a physician for use in
    children under 6 years of age.


    Use additionally as needed, up
    to 6 times per day.

    Reference image: Great lakes us.jpg

  • OTHER SAFETY INFORMATION

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

    Keep carton for complete drug facts and product information.

    Questions? Call 866.298.2740

    King Bio, Inc. 3 Westside Drive

    Asheville, NC 2806 USA

    FDA Reg. #1053442

    For latest product information and instructions: www.DrKings.com

    Reference image: Great lakes us.jpg

  • Inactive Ingredients

    Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

    Reference image: Great lakes us.jpg

  • Active ingredients

    Equal volumes of each HPUS ingredient in 12X, 30X, and 1LM
    potencies.

    Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin (30X), Allium cepa, Ambrosia artemisiaefolia, Arum triphyllum, Arundo mauritanica, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Natrum muriaticum, Pulsatilla, RNA, Sabadilla, Teucrium scorodonia.

    **“HPUS” indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

    Reference image: Great lakes us.jpg

  • Uses

    For temporary relief of allergy symptoms commonly
    experienced in IA, IL, IN, MI, MN, MO, OH, WI:

    itchy, watery eyes 

    runny nose 

    sneezing 

    sore throat

    sinus congestion 

    cough 

    stuffy nose 

    fatigue

    itchy, irritated skin 

    hoarseness 

    headache

    † as per various homeopathic materia medicas. Claims based
    on traditional homeopathic practice, not accepted medical
    evidence. These uses have not been evaluated by the FDA,
    and product has not been clinically tested.

    Reference image: Great lakes us.jpg

  • Warnings

    Stop use and consult a physician if symptoms worsen or
    persist for more than 7 days.

    If pregnant or breast-feeding, ask a healthcare professional
    before use.
    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center immediately.

    Reference image: Great lakes us.jpg

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center immediately.

    Reference image: Great lakes us.jpg

  • PURPOSE

    Adenosinum cyclophosphoricum..............headache, runny nose
    Adrenalinum ........... hay fever, swollen sinuses, lung congestion
    Adrenocorticotrophin (30X) ............................congestion, cough
    Allium cepa........................hay fever, sinus headache, sneezing
    Ambrosia artemisiaefolia ......................hay fever, wheezy cough
    Arum triphyllum ..........inflammation of nasal mucus membranes
    Arundo mauritanica ........................nasal congestion and itching
    Chelidonium majus................. mucus in eyes, spasmodic cough
    Chenopodium vulvaria.......restlessness, left-side head pressure
    Cichorium intybus......................fatigue, headache, eye irritation
    Cortisone aceticum.............................allergic reaction, irritability
    Euphrasia officinalis.....................discharge from eyes and nose
    Galphimia glauca ............................... swollen eyelids, hay fever
    Hedera helix .............catarrhal inflammation, cough with sputum
    Histaminum hydrochloricum ............. coughing fits, itching throat
    Juglans cinerea ............red, swollen eyes, sneezing, sore throat
    Kali muriaticum....................hoarseness, stuffy nose, nosebleed
    Natrum muriaticum ...................................watery eyes, sneezing
    Pulsatilla ........................ pain in head and eyes, mucus in throat
    RNA ................................................................. .allergic reactions
    Sabadilla.......................... .sore throat, runny nose, sneezing fits
    Teucrium scorodonia .... .bronchial congestion with much mucus

    HPUS” indicates the active ingredients are in the official
    Homeopathic Pharmacopeia of the United States.

    Reference image: Great lakes us.jpg

  • PRINCIPAL DISPLAY PANEL

    image description Great lakes us.jpg

  • INGREDIENTS AND APPEARANCE
    REGIONAL ALLERGIES GREAT LAKES U.S. 
    adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, arum triphyllum, arundo mauritanica, chelidonium majus, chenopodium vulvaria, cichorium intybus, cortisone aceticum, euphrasia officinalis, galphimia glauca, hedera helix, histaminum hydrochloricum, juglans cinerea, kali muriaticum, natrum muriaticum, pulsatilla, rna, sabadilla, teucrium scorodonia. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-2807
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) (ADENOSINE CYCLIC PHOSPHATE - UNII:E0399OZS9N) ADENOSINE CYCLIC PHOSPHATE12 [hp_X]  in 59 mL
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE12 [hp_X]  in 59 mL
    CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA) CORTICOTROPIN30 [hp_X]  in 59 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION30 [hp_X]  in 59 mL
    AMBROSIA ARTEMISIIFOLIA WHOLE (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA WHOLE12 [hp_X]  in 59 mL
    ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM) ARISAEMA TRIPHYLLUM ROOT12 [hp_X]  in 59 mL
    ARUNDO PLINIANA ROOT (UNII: ZXE7LB03WC) (ARUNDO PLINIANA ROOT - UNII:ZXE7LB03WC) ARUNDO PLINIANA ROOT12 [hp_X]  in 59 mL
    CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE112 [hp_X]  in 59 mL
    CHENOPODIUM VULVARIA WHOLE (UNII: 0VSD1H8IW4) (CHENOPODIUM VULVARIA WHOLE - UNII:0VSD1H8IW4) CHENOPODIUM VULVARIA WHOLE12 [hp_X]  in 59 mL
    CHICORY ROOT (UNII: 090CTY533N) (CHICORY ROOT - UNII:090CTY533N) CHICORY ROOT12 [hp_X]  in 59 mL
    CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE12 [hp_X]  in 59 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA12 [hp_X]  in 59 mL
    GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP12 [hp_X]  in 59 mL
    HEDERA HELIX FLOWERING TWIG (UNII: 3D10KUA6BM) (HEDERA HELIX FLOWERING TWIG - UNII:3D10KUA6BM) HEDERA HELIX FLOWERING TWIG12 [hp_X]  in 59 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE12 [hp_X]  in 59 mL
    JUGLANS CINEREA BRANCH BARK/ROOT BARK (UNII: 48FZ1BHO18) (JUGLANS CINEREA BRANCH BARK/ROOT BARK - UNII:48FZ1BHO18) JUGLANS CINEREA BRANCH BARK/ROOT BARK12 [hp_X]  in 59 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CATION12 [hp_X]  in 59 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE12 [hp_X]  in 59 mL
    PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE12 [hp_X]  in 59 mL
    SACCHAROMYCES CEREVISIAE RNA (UNII: J17GBZ5VGX) (SACCHAROMYCES CEREVISIAE RNA - UNII:J17GBZ5VGX) SACCHAROMYCES CEREVISIAE RNA12 [hp_X]  in 59 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED12 [hp_X]  in 59 mL
    TEUCRIUM SCORODONIA FLOWERING TOP (UNII: LOK3I16O7G) (TEUCRIUM SCORODONIA FLOWERING TOP - UNII:LOK3I16O7G) TEUCRIUM SCORODONIA FLOWERING TOP12 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    STEVIOL (UNII: 4741LYX6RT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-2807-21 in 1 CARTON04/14/2022
    159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/14/2022
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-2807) , api manufacture(57955-2807)