Label: SOUTHEAST REGIONAL ALLERGIES- adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, alnus serrulata, carduus benedictus, cichorium intybus, cortisone aceticum, dolichos pruriens, euphrasia officinalis, galphimia glauca, histaminum hydrochloricum, juglans cinerea, kali muriaticum, mucosa nasalis suis, nasturtium aquaticum, natrum muriaticum, rna, rhus toxicodendron, sabadilla, sassafras officinale 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, Alnus serrulata, Carduus benedictus, Cichorium intybus, Cortisone aceticum, Dolichos pruriens, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Nasturtium aquaticum, Natrum muriaticum, RNA, Rhus toxicodendron, Sabadilla, Sassafras officinale.

  • INDICATIONS & USAGE

    Uses for temporary relief of allergy symptoms commonly experienced in AL, AR, DC, DE, FL, GA, KY, LA, MD, MS, NC, SC, TN, VA, WV:

    • 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

    Alnus serrulata...................................................................hay fever

    Carduus benedictus.............................................................tickling in nose

    Cichorium intybus................................................................fatigue, headache

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

    Dolichos pruriens..................................................................sore throat, itchy skin

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

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

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

    Juglans cinerea....................................................................red swollen eyes, sneezing, sore throat

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

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

    Nasturtium aquaticum..........................................................urinary tract and or liver congestion

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

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

    Rhus toxicodendron..............................................................dry cough, sneezing, swelling of nose

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

    Sassafras officinale...............................................................swollen eyes

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SOUTHEAST REGIONAL ALLERGIES 
    adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, alnus serrulata, carduus benedictus, cichorium intybus, cortisone aceticum, dolichos pruriens, euphrasia officinalis, galphimia glauca, histaminum hydrochloricum, juglans cinerea, kali muriaticum, mucosa nasalis suis, nasturtium aquaticum, natrum muriaticum, rna, rhus toxicodendron, sabadilla, sassafras officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-8345
    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
    ALNUS SERRULATA BARK (UNII: BQ5P19J9OL) (ALNUS SERRULATA BARK - UNII:BQ5P19J9OL) ALNUS SERRULATA BARK10 [hp_X]  in 29.6 mL
    CENTAUREA BENEDICTA (UNII: 6L5ZL09795) (CENTAUREA BENEDICTA - UNII:6L5ZL09795) CENTAUREA BENEDICTA10 [hp_X]  in 29.6 mL
    CHICORY ROOT (UNII: 090CTY533N) (CHICORY ROOT - UNII:090CTY533N) CHICORY ROOT10 [hp_X]  in 29.6 mL
    CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE10 [hp_X]  in 29.6 mL
    MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C) MUCUNA PRURIENS FRUIT TRICHOME10 [hp_X]  in 29.6 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA10 [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
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE10 [hp_X]  in 29.6 mL
    JUGLANS CINEREA BRANCH BARK/ROOT BARK (UNII: 48FZ1BHO18) (JUGLANS CINEREA BRANCH BARK/ROOT BARK - UNII:48FZ1BHO18) JUGLANS CINEREA BRANCH BARK/ROOT BARK10 [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
    NASTURTIUM OFFICINALE (UNII: YH89GMV676) (NASTURTIUM AQUATICUM - UNII:YH89GMV676) NASTURTIUM OFFICINALE10 [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
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [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
    SASSAFRAS ALBIDUM ROOT BARK (UNII: XC5UMP9I5F) (SASSAFRAS ALBIDUM ROOT BARK - UNII:XC5UMP9I5F) SASSAFRAS ALBIDUM ROOT BARK10 [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:57955-8345-11 in 1 CARTON
    129.6 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/31/2013
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(57955-8345)