Label: REGIONAL ALLERGIES GREAT LAKES U.S.- adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, arum triphyllum, arundo mauritanica, chelidonium majus, chenopodium vulvaria, cichorium intybus, cortisone aceticum, euphrasia officinalis, galphimia glauca, hedera helix, histaminum hydrochloricum, juglans cinerea, kali muriaticum, natrum muriaticum, pulsatilla, rna, sabadilla, teucrium scorodonia. liquid
- NDC Code(s): 57955-2807-2
- 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 September 7, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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.
Consult a physician for use in
children under 6 years of age.
Use additionally as needed, up
to 6 times per day.Reference image: Great lakes us.jpg
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OTHER SAFETY INFORMATION
Other information
Tamper resistant for your protection.
Use only if safety seal is intact.Keep carton for complete drug facts and product information.
Questions? Call 866.298.2740
King Bio, Inc. 3 Westside Drive
Asheville, NC 2806 USA
FDA Reg. #1053442
For latest product information and instructions: www.DrKings.com
Reference image: Great lakes us.jpg
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Inactive Ingredients
Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).
Reference image: Great lakes us.jpg
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Active ingredients
Equal volumes of each HPUS ingredient in 12X, 30X, and 1LM
potencies.Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin (30X), Allium cepa, Ambrosia artemisiaefolia, Arum triphyllum, Arundo mauritanica, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Natrum muriaticum, Pulsatilla, RNA, Sabadilla, Teucrium scorodonia.
**“HPUS” indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.
Reference image: Great lakes us.jpg
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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. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested.Reference image: Great lakes us.jpg
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Warnings
Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.If pregnant or breast-feeding, ask a healthcare professional
before use.
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center immediately.
Reference image: Great lakes us.jpg
- KEEP OUT OF REACH OF CHILDREN
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PURPOSE
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
Arum triphyllum ..........inflammation of nasal mucus membranes
Arundo mauritanica ........................nasal congestion and itching
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
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 mucusHPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States.Reference image: Great lakes us.jpg
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REGIONAL ALLERGIES GREAT LAKES U.S.
adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, arum triphyllum, arundo mauritanica, chelidonium majus, chenopodium vulvaria, cichorium intybus, cortisone aceticum, euphrasia officinalis, galphimia glauca, hedera helix, histaminum hydrochloricum, juglans cinerea, kali muriaticum, natrum muriaticum, pulsatilla, rna, sabadilla, teucrium scorodonia. liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-2807 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 30 [hp_X] in 59 mL AMBROSIA ARTEMISIIFOLIA WHOLE (UNII: 9W34L2CQ9A) (AMBROSIA ARTEMISIIFOLIA - UNII:9W34L2CQ9A) AMBROSIA ARTEMISIIFOLIA WHOLE 12 [hp_X] in 59 mL ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM) ARISAEMA TRIPHYLLUM ROOT 12 [hp_X] in 59 mL ARUNDO PLINIANA ROOT (UNII: ZXE7LB03WC) (ARUNDO PLINIANA ROOT - UNII:ZXE7LB03WC) ARUNDO PLINIANA ROOT 12 [hp_X] in 59 mL CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE 112 [hp_X] in 59 mL CHENOPODIUM VULVARIA WHOLE (UNII: 0VSD1H8IW4) (CHENOPODIUM VULVARIA WHOLE - UNII:0VSD1H8IW4) CHENOPODIUM VULVARIA WHOLE 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 SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 12 [hp_X] in 59 mL PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS 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 ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) ORANGE PEEL (UNII: TI9T76XD44) CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY) CARYA OVATA BARK (UNII: X765CF609L) STEVIOL (UNII: 4741LYX6RT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-2807-2 1 in 1 CARTON 04/14/2022 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 04/14/2022 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-2807) , api manufacture(57955-2807)