Southeast Regional Allergies: Homeopathic Product Information

SOUTHEAST REGIONAL ALLERGIES- adenosine cyclic phosphate, epinephrine, corticotropin, onion, alnus serrulata bark, centaurea benedicta, chicory root, cortisone acetate, mucuna pruriens fruit trichome, euphrasia stricta, galphimia glauca flowering top, histamine dihydrochloride, juglans cinerea branch bark/root bark, potassium chloride, sus scrofa nasal mucosa, nasturtium officinale, sodium chloride, saccharomyces cerevisiae rna, toxicodendron pubescens leaf, schoenocaulon officinale seed and sassafras albidum root bark liquid
King Bio Inc.

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 Facts

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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.

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

  • 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.

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.

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

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

Drug Facts

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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

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:57955-8345
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADENOSINE CYCLIC PHOSPHATE (ADENOSINE CYCLIC 3′,5′-PHOSPHATE) ADENOSINE CYCLIC PHOSPHATE 10 [hp_X] in 29.6 mL
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 10 [hp_X] in 29.6 mL
CORTICOTROPIN (CORTICOTROPIN) CORTICOTROPIN 10 [hp_X] in 29.6 mL
ONION (ONION) ONION 10 [hp_X] in 29.6 mL
ALNUS SERRULATA BARK (ALNUS SERRULATA BARK) ALNUS SERRULATA BARK 10 [hp_X] in 29.6 mL
CENTAUREA BENEDICTA (CENTAUREA BENEDICTA) CENTAUREA BENEDICTA 10 [hp_X] in 29.6 mL
CHICORY ROOT (CHICORY ROOT) CHICORY ROOT 10 [hp_X] in 29.6 mL
CORTISONE ACETATE (CORTISONE) CORTISONE ACETATE 10 [hp_X] in 29.6 mL
MUCUNA PRURIENS FRUIT TRICHOME (MUCUNA PRURIENS FRUIT TRICHOME) MUCUNA PRURIENS FRUIT TRICHOME 10 [hp_X] in 29.6 mL
EUPHRASIA STRICTA (EUPHRASIA STRICTA) EUPHRASIA STRICTA 10 [hp_X] in 29.6 mL
GALPHIMIA GLAUCA FLOWERING TOP (GALPHIMIA GLAUCA FLOWERING TOP) GALPHIMIA GLAUCA FLOWERING TOP 10 [hp_X] in 29.6 mL
HISTAMINE DIHYDROCHLORIDE (HISTAMINE) HISTAMINE DIHYDROCHLORIDE 10 [hp_X] in 29.6 mL
JUGLANS CINEREA BRANCH BARK/ROOT BARK (JUGLANS CINEREA BRANCH BARK/ROOT BARK) JUGLANS CINEREA BRANCH BARK/ROOT BARK 10 [hp_X] in 29.6 mL
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 10 [hp_X] in 29.6 mL
SUS SCROFA NASAL MUCOSA (SUS SCROFA NASAL MUCOSA) SUS SCROFA NASAL MUCOSA 10 [hp_X] in 29.6 mL
NASTURTIUM OFFICINALE (NASTURTIUM AQUATICUM) NASTURTIUM OFFICINALE 10 [hp_X] in 29.6 mL
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 10 [hp_X] in 29.6 mL
SACCHAROMYCES CEREVISIAE RNA (SACCHAROMYCES CEREVISIAE RNA) SACCHAROMYCES CEREVISIAE RNA 10 [hp_X] in 29.6 mL
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 29.6 mL
SCHOENOCAULON OFFICINALE SEED (SCHOENOCAULON OFFICINALE SEED) SCHOENOCAULON OFFICINALE SEED 10 [hp_X] in 29.6 mL
SASSAFRAS ALBIDUM ROOT BARK (SASSAFRAS ALBIDUM ROOT BARK) SASSAFRAS ALBIDUM ROOT BARK 10 [hp_X] in 29.6 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57955-8345-1 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
1 29.6 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (57955-8345-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/31/2013
Labeler — King Bio Inc. (617901350)
Registrant — King Bio Inc. (617901350)
Establishment
Name Address ID/FEI Operations
King Bio Inc. 617901350 api manufacture (57955-8345)

Revised: 11/2013 King Bio Inc.

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