Label: REGIONAL ALLERGIES GREAT LAKES U.S.- adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, chelidonium majus, chenopodium vulvaria, cichorium intybus, cortisone aceticum, euphrasia officinalis, galphimia glauca, hedera helix, histaminum hydrochloricum, juglans cinerea, kali muriaticum, mucosa nasalis suis, natrum muriaticum, pulsatilla, rna, sabadilla, teucrium scorodonia liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-0752-2 - 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 8, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients: Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin(30X), Allium cepa, Ambrosia artemisiaefolia, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Pulsatilla, RNA, Sabadilla, Teucrium scorodonia.
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INDICATIONS & USAGE
Uses for temporary relief of allergy symptoms commonly experienced in IA, IL, IN, MI, MN, MO, OH, WI: •itchy, watery eyes •runny nose •sneezing •sore throat •sinus congestion •cough •stuffy nose •fatigue •itchy, irritated skin •hoarseness •headache.
† as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.
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INACTIVE INGREDIENT
Inactive Ingredients:
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
Drug Facts
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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
Ambrosia artemisiaefolia......................hay fever, wheezy cough
Chelidonium majus.................mucus in eyes, spasmodic cough
Chenopodium vulvaria.......restlessness, left-side head pressure
Cichorium intybus......................fatigue, headache, eye irritation
Cortisone aceticum.............................allergic reaction, irritability
Euphrasia officinalis.....................discharge from eyes and nose
Galphimia glauca ...............................swollen eyelids, hay fever
Hedera helix .............catarrhal inflammation, cough with sputum
Histaminum hydrochloricum............. coughing fits, itching throat
Juglans cinerea ............red, swollen eyes, sneezing, sore throat
Kali muriaticum....................hoarseness, stuffy nose, nosebleed
Mucosa nasalis suis ..............sinus headache, nasal congestion
Natrum muriaticum...................................watery eyes, sneezing
Pulsatilla........................ pain in head and eyes, mucus in throat
RNA..................................................................allergic reactions
Sabadilla...........................sore throat, runny nose, sneezing fits
Teucrium scorodonia .... .bronchial congestion with much mucus
**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States.
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INGREDIENTS AND APPEARANCE
REGIONAL ALLERGIES GREAT LAKES U.S.
adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, chelidonium majus, chenopodium vulvaria, cichorium intybus, cortisone aceticum, euphrasia officinalis, galphimia glauca, hedera helix, histaminum hydrochloricum, juglans cinerea, kali muriaticum, mucosa nasalis suis, natrum muriaticum, pulsatilla, rna, sabadilla, teucrium scorodonia liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0752 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 AMBROSIA ARTEMISIIFOLIA (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA 12 [hp_X] in 59 mL CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 12 [hp_X] in 59 mL CHENOPODIUM VULVARIA (UNII: 0VSD1H8IW4) (CHENOPODIUM VULVARIA - UNII:0VSD1H8IW4) CHENOPODIUM VULVARIA 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 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 HEDERA HELIX FLOWERING TWIG (UNII: 3D10KUA6BM) (HEDERA HELIX FLOWERING TWIG - UNII:3D10KUA6BM) HEDERA HELIX FLOWERING TWIG 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 CATION 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 PULSATILLA PATENS WHOLE (UNII: 4M1169RWJD) (PULSATILLA PATENS WHOLE - UNII:4M1169RWJD) PULSATILLA PATENS WHOLE 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 TEUCRIUM SCORODONIA FLOWERING TOP (UNII: LOK3I16O7G) (TEUCRIUM SCORODONIA FLOWERING TOP - UNII:LOK3I16O7G) TEUCRIUM SCORODONIA FLOWERING TOP 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:57955-0752-2 1 in 1 CARTON 04/11/2018 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 04/11/2018 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-0752) , api manufacture(57955-0752)