Label: REGIONAL ALLERGIES ROCKY MTNS. U.S.- adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, agrimonia eupatoria, agrostemma githago, ailanthus glandulosus, allium cepa, cortisone aceticum, cynodon dactylon, equisetum hyemale, euphrasia officinalis, galphimia glauca, histaminum hydrochloricum, kali muriaticum, mucosa nasalis suis, natrum muriaticum, platanus, populus candicans, rna, sabadilla, solidago virgaurea liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-8200-2 - 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 October 11, 2013
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ACTIVE INGREDIENT
Drug Facts
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HPUS active ingredients: Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Agrimonia eupatoria, Agrostemma githago, Ailanthus glandulosus, Allium cepa, Cortisone aceticum, Cynodon dactylon, Equisetum hyemale, Euphrasia officinalis, Galphimia glauca, Histaminum hydrochloricum, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Platanus, Populus candicans, RNA, Sabadilla, Solidago virgaurea.
- 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 12X, 30X, and LM1 potencies.
Adenosinum cyclophosphoricum........................................................headache, runny nose
Adrenalinum...................................................................................hay fever, swollen sinuses, lung congestion
Adrenocorticotrophin........................................................................inflammation, congestion, cough
Agrimonia eupatoria.........................................................................anxiety, restlessness
Agrostemma githago........................................................................headache, vertigo, dry mouth
Ailanthus glandulosus.......................................................................hoarseness, drowsiness, dry cough
Allium cepa.....................................................................................hay fever, sinus headache, sneezing
Cortisone aceticum...........................................................................allergic reaction, irritability
Cynodon dactylon.............................................................................swollen eyelids, loss of sense of taste
Equisetum hyemale..........................................................................heavy eyelids, sticking pain in throat
Euphrasia officinalis..........................................................................discharge from eyes and nose
Galphimia glauca..............................................................................swollen eyelids, hay fever
Histaminum hydrochloricum...............................................................coughing fits, itching throat
Kali muriaticum................................................................................hoarseness, stuffy nose, nosebleed
Mucosa nasalis suis...........................................................................sinus headache, nasal congestion
Natrum muriaticum...........................................................................watery eyes, sneezing
Platanus...........................................................................................weakness in eyes
Populus candicans..............................................................................sore chest and throat, hoarseness
RNA.................................................................................................allergic reactions
Sabadilla...........................................................................................sore throat, runny nose, sneezing fits
Solidago virgaurea..............................................................................bronchitis, heavy expectoration
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REGIONAL ALLERGIES ROCKY MTNS. U.S.
adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, agrimonia eupatoria, agrostemma githago, ailanthus glandulosus, allium cepa, cortisone aceticum, cynodon dactylon, equisetum hyemale, euphrasia officinalis, galphimia glauca, histaminum hydrochloricum, kali muriaticum, mucosa nasalis suis, natrum muriaticum, platanus, populus candicans, rna, sabadilla, solidago virgaurea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-8200 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 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 12 [hp_X] in 59 mL AGRIMONIA EUPATORIA (UNII: EBU0U94820) (AGRIMONIA EUPATORIA - UNII:EBU0U94820) AGRIMONIA EUPATORIA 12 [hp_X] in 59 mL AGROSTEMMA GITHAGO SEED (UNII: W4374IBY05) (AGROSTEMMA GITHAGO SEED - UNII:W4374IBY05) AGROSTEMMA GITHAGO SEED 12 [hp_X] in 59 mL AILANTHUS ALTISSIMA FLOWERING TWIG (UNII: 8P29O5P7XU) (AILANTHUS ALTISSIMA FLOWERING TWIG - UNII:8P29O5P7XU) AILANTHUS ALTISSIMA FLOWERING TWIG 12 [hp_X] in 59 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 12 [hp_X] in 59 mL CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE 12 [hp_X] in 59 mL CYNODON DACTYLON (UNII: 2Q8MR21NHK) (CYNODON DACTYLON - UNII:2Q8MR21NHK) CYNODON DACTYLON 12 [hp_X] in 59 mL EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE 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 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 12 [hp_X] in 59 mL PLATANUS OCCIDENTALIS WHOLE (UNII: A8520YN83L) (PLATANUS OCCIDENTALIS WHOLE - UNII:A8520YN83L) PLATANUS OCCIDENTALIS WHOLE 12 [hp_X] in 59 mL POPULUS BALSAMIFERA LEAF BUD (UNII: 9CQ6C00G3C) (POPULUS BALSAMIFERA LEAF BUD - UNII:9CQ6C00G3C) POPULUS BALSAMIFERA LEAF BUD 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 SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 12 [hp_X] in 59 mL SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP 12 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-8200-2 1 in 1 CARTON 1 59 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/12/2013 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 api manufacture(57955-8200)