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

Southeast Regional Allergies by

Drug Labeling and Warnings

Southeast Regional Allergies by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57955-8345
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) (ADENOSINE CYCLIC 3',5'-PHOSPHATE - UNII:E0399OZS9N)	ADENOSINE CYCLIC PHOSPHATE	10 [hp_X]  in 29.6 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	10 [hp_X]  in 29.6 mL
CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA)	CORTICOTROPIN	10 [hp_X]  in 29.6 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	10 [hp_X]  in 29.6 mL
ALNUS SERRULATA BARK (UNII: BQ5P19J9OL) (ALNUS SERRULATA BARK - UNII:BQ5P19J9OL)	ALNUS SERRULATA BARK	10 [hp_X]  in 29.6 mL
CENTAUREA BENEDICTA (UNII: 6L5ZL09795) (CENTAUREA BENEDICTA - UNII:6L5ZL09795)	CENTAUREA BENEDICTA	10 [hp_X]  in 29.6 mL
CHICORY ROOT (UNII: 090CTY533N) (CHICORY ROOT - UNII:090CTY533N)	CHICORY ROOT	10 [hp_X]  in 29.6 mL
CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ)	CORTISONE ACETATE	10 [hp_X]  in 29.6 mL
MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C)	MUCUNA PRURIENS FRUIT TRICHOME	10 [hp_X]  in 29.6 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	10 [hp_X]  in 29.6 mL
GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E)	GALPHIMIA GLAUCA FLOWERING TOP	10 [hp_X]  in 29.6 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	10 [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 BARK	10 [hp_X]  in 29.6 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	10 [hp_X]  in 29.6 mL
SUS SCROFA NASAL MUCOSA (UNII: ID3Z1X61WY) (SUS SCROFA NASAL MUCOSA - UNII:ID3Z1X61WY)	SUS SCROFA NASAL MUCOSA	10 [hp_X]  in 29.6 mL
NASTURTIUM OFFICINALE (UNII: YH89GMV676) (NASTURTIUM AQUATICUM - UNII:YH89GMV676)	NASTURTIUM OFFICINALE	10 [hp_X]  in 29.6 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	10 [hp_X]  in 29.6 mL
SACCHAROMYCES CEREVISIAE RNA (UNII: J17GBZ5VGX) (SACCHAROMYCES CEREVISIAE RNA - UNII:J17GBZ5VGX)	SACCHAROMYCES CEREVISIAE RNA	10 [hp_X]  in 29.6 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	10 [hp_X]  in 29.6 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	10 [hp_X]  in 29.6 mL
SASSAFRAS ALBIDUM ROOT BARK (UNII: XC5UMP9I5F) (SASSAFRAS ALBIDUM ROOT BARK - UNII:XC5UMP9I5F)	SASSAFRAS ALBIDUM ROOT BARK	10 [hp_X]  in 29.6 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57955-8345-1	1 in 1 CARTON
1		29.6 mL in 1 BOTTLE, SPRAY

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	Business Operations
King Bio Inc.		617901350	api manufacture(57955-8345)