Label: REGIONAL ALLERGIES SOUTHERN U.S.- 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, rhus tox, rna, sabadilla, sassafras officinale liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-0760-2 - Packager: King Bio Inc.
- Category: HUMAN OTC DRUG LABEL
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 July 9, 2020
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ACTIVE INGREDIENT
Drug Facts
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HPUS active ingredients: Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin (30X), 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, Rhus tox, RNA, Sabadilla, Sassafras officinale.
Equal volumes of each ingredient in 12X, 30X, and 1LM.
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Bio-Energetically Enhanced™ pure
water, citrus extract* (ascorbic
acid, citric acid, citrus aurantium
amara fruit extract, citrus
aurantium sinensis peel extract,
citrus reticulata fruit extract,
demineralized water, glycerin,
lactic acid), Honeysuckle (Lonicera
japonica), polylysine, Shagbark
Hickory (Carya ovata) Bark
Extract, steviol (Steviol
glycosides). -
PURPOSE
HPUS active ingredients Purpose
Equal volumes of each HPUS** ingredient in 12X, 30X, and 1LM
potencies unless otherwise noted.
Adenosinum cyclophosphoricum..............headache, runny nose
Adrenalinum ...........hay fever, swollen sinuses, lung congestion
Adrenocorticotrophin (30X) ............................congestion, cough
Allium cepa........................hay fever, sinus headache, sneezing
Alnus serrulata ............................................hay fever, bronchitis
Carduus benedictus .............................................tickling in nose
Cichorium intybus............................................fatigue, headache
Cortisone aceticum.............................allergic reaction, irritability
Dolichos pruriens.......................................sore throat, itchy skin
Euphrasia officinalis.....................discharge from eyes and nose
Galphimia glauca.................................... puffy eyelids, hay fever
Histaminum hydrochloricum...................coughing, itching throat
Juglans cinerea ..........................red eyes, sneezing, sore throat
Kali muriaticum......................................hoarseness, stuffy nose
Mucosa nasalis suis ..............sinus headache, nasal congestion
Nasturtium aquaticum .................... sensitivity to cigarette toxins
Natrum muriaticum...................................watery eyes, sneezing
Rhus tox .......................... dry cough, sneezing, swelling of nose
RNA..................................................................allergic reactions
Sabadilla.................................sore throat, runny nose, sneezing
Sassafras officinale ..............................minor breathing difficulty
**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REGIONAL ALLERGIES SOUTHERN U.S.
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, rhus tox, rna, sabadilla, sassafras officinale liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0760 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ADENOSINE CYCLIC PHOSPHATE (UNII: E0399OZS9N) (ADENOSINE CYCLIC PHOSPHATE - UNII:E0399OZS9N) ADENOSINE CYCLIC PHOSPHATE 12 [hp_X] in 59 mL EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE 12 [hp_X] in 59 mL CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA) CORTICOTROPIN 30 [hp_X] in 59 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 12 [hp_X] in 59 mL ALNUS SERRULATA BARK (UNII: BQ5P19J9OL) (ALNUS SERRULATA BARK - UNII:BQ5P19J9OL) ALNUS SERRULATA BARK 12 [hp_X] in 59 mL CENTAUREA BENEDICTA (UNII: 6L5ZL09795) (CENTAUREA BENEDICTA - UNII:6L5ZL09795) CENTAUREA BENEDICTA 12 [hp_X] in 59 mL CHICORY ROOT (UNII: 090CTY533N) (CHICORY ROOT - UNII:090CTY533N) CHICORY ROOT 12 [hp_X] in 59 mL CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE 12 [hp_X] in 59 mL MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C) MUCUNA PRURIENS FRUIT TRICHOME 12 [hp_X] in 59 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 12 [hp_X] in 59 mL GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP 12 [hp_X] in 59 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 12 [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 BARK 12 [hp_X] in 59 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 12 [hp_X] in 59 mL SUS SCROFA NASAL MUCOSA (UNII: ID3Z1X61WY) (SUS SCROFA NASAL MUCOSA - UNII:ID3Z1X61WY) SUS SCROFA NASAL MUCOSA 12 [hp_X] in 59 mL NASTURTIUM OFFICINALE (UNII: YH89GMV676) (NASTURTIUM OFFICINALE - UNII:YH89GMV676) NASTURTIUM OFFICINALE 12 [hp_X] in 59 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 12 [hp_X] in 59 mL SACCHAROMYCES CEREVISIAE RNA (UNII: J17GBZ5VGX) (SACCHAROMYCES CEREVISIAE RNA - UNII:J17GBZ5VGX) SACCHAROMYCES CEREVISIAE RNA 12 [hp_X] in 59 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 12 [hp_X] in 59 mL SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 12 [hp_X] in 59 mL SASSAFRAS ALBIDUM ROOT BARK (UNII: XC5UMP9I5F) (SASSAFRAS ALBIDUM ROOT BARK - UNII:XC5UMP9I5F) SASSAFRAS ALBIDUM ROOT BARK 12 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARYA OVATA BARK (UNII: X765CF609L) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR) REBAUDIOSIDE A (UNII: B3FUD0528F) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-0760-2 1 in 1 CARTON 04/19/2018 1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/19/2018 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-0760) , api manufacture(57955-0760)