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
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-8345-1 - Packager: King Bio Inc.
- 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
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ACTIVE INGREDIENT
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.
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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PURPOSE
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
- PRINCIPAL DISPLAY PANEL
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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 liquidProduct 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)