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.

King Bio Inc.
Human Otc Drug
NDC 57955-2807

Regional Allergies Great Lakes U.s. also known as 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. is a human otc drug labeled by 'King Bio Inc.'. National Drug Code (NDC) number for Regional Allergies Great Lakes U.s. is 57955-2807. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Regional Allergies Great Lakes U.s. drug includes Adenosine Cyclic Phosphate - 12 [hp_X]/59mL Ambrosia Artemisiifolia Whole - 12 [hp_X]/59mL Arisaema Triphyllum Root - 12 [hp_X]/59mL Arundo Pliniana Root - 12 [hp_X]/59mL Chelidonium Majus Whole - 112 [hp_X]/59mL Chenopodium Vulvaria Whole - 12 [hp_X]/59mL Chicory Root - 12 [hp_X]/59mL Corticotropin - 30 [hp_X]/59mL Cortisone Acetate - 12 [hp_X]/59mL Epinephrine - 12 [hp_X]/59mL and more. The currest status of Regional Allergies Great Lakes U.s. drug is Active.

Drug Information:

Drug NDC:	57955-2807
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Regional Allergies Great Lakes U.s.
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	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.
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	King Bio Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Liquid
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ADENOSINE CYCLIC PHOSPHATE - 12 [hp_X]/59mL AMBROSIA ARTEMISIIFOLIA WHOLE - 12 [hp_X]/59mL ARISAEMA TRIPHYLLUM ROOT - 12 [hp_X]/59mL ARUNDO PLINIANA ROOT - 12 [hp_X]/59mL CHELIDONIUM MAJUS WHOLE - 112 [hp_X]/59mL CHENOPODIUM VULVARIA WHOLE - 12 [hp_X]/59mL CHICORY ROOT - 12 [hp_X]/59mL CORTICOTROPIN - 30 [hp_X]/59mL CORTISONE ACETATE - 12 [hp_X]/59mL EPINEPHRINE - 12 [hp_X]/59mL Load more... EUPHRASIA STRICTA - 12 [hp_X]/59mL GALPHIMIA GLAUCA FLOWERING TOP - 12 [hp_X]/59mL HEDERA HELIX FLOWERING TWIG - 12 [hp_X]/59mL HISTAMINE DIHYDROCHLORIDE - 12 [hp_X]/59mL JUGLANS CINEREA BRANCH BARK/ROOT BARK - 12 [hp_X]/59mL ONION - 30 [hp_X]/59mL POTASSIUM CHLORIDE - 12 [hp_X]/59mL PULSATILLA VULGARIS WHOLE - 12 [hp_X]/59mL SACCHAROMYCES CEREVISIAE RNA - 12 [hp_X]/59mL SCHOENOCAULON OFFICINALE SEED - 12 [hp_X]/59mL SODIUM CHLORIDE - 12 [hp_X]/59mL TEUCRIUM SCORODONIA FLOWERING TOP - 12 [hp_X]/59mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	14 Apr, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	24 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	King Bio Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	M0000499 N0000175941 N0000000209 N0000000245 N0000175552 N0000175555 N0000175570 M0003647 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0022575
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	E0399OZS9N 9W34L2CQ9A DM64K844DM ZXE7LB03WC 7E889U5RNN 0VSD1H8IW4 090CTY533N K0U68Q2TXA 883WKN7W8X YKH834O4BH Load more... C9642I91WL 93PH5Q8M7E 3D10KUA6BM 3POA0Q644U 48FZ1BHO18 492225Q21H 660YQ98I10 I76KB35JEV J17GBZ5VGX 6NAF1689IO 451W47IQ8X LOK3I16O7G
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:	Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	Adrenocorticotropic Hormone [EPC] alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [EPC] Catecholamine [EPC] Non-Standardized Food Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Adrenocorticotropic Hormone [CS] Catecholamines [CS] Allergens [CS] Dietary Proteins [CS] Vegetable Proteins [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA] Adrenocorticotropic Hormone [CS] Adrenocorticotropic Hormone [EPC] Allergens [CS] Catecholamine [EPC] Catecholamines [CS] Cell-mediated Immunity [PE] Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC] Dietary Proteins [CS] Increased Histamine Release [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Non-Standardized Food Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Potassium Compounds [CS] Potassium Salt [EPC] Vegetable Proteins [CS] alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
57955-2807-2	1 BOTTLE, SPRAY in 1 CARTON (57955-2807-2) / 59 mL in 1 BOTTLE, SPRAY	14 Apr, 2022	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Regional Allergies Great Lakes U.s.

Adenosinum Cyclophosphoricum & more..

Liquid
King Bio Inc.
NDC: 57955-2807

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 mucus hpusâ indicates the active ingredients are in the official homeopathic pharmacopeia of the united states. reference image: great lakes us.jpg

Product Elements:

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. adenosine cyclic phosphate adenosine cyclic phosphate epinephrine epinephrine corticotropin corticotropin onion onion ambrosia artemisiifolia whole ambrosia artemisiifolia arisaema triphyllum root arisaema triphyllum root arundo pliniana root arundo pliniana root chelidonium majus whole chelidonium majus chenopodium vulvaria whole chenopodium vulvaria whole chicory root chicory root cortisone acetate cortisone euphrasia stricta euphrasia stricta galphimia glauca flowering top galphimia glauca flowering top hedera helix flowering twig hedera helix flowering twig histamine dihydrochloride histamine juglans cinerea branch bark/root bark juglans cinerea branch bark/root bark potassium chloride potassium cation sodium chloride chloride ion pulsatilla vulgaris whole anemone pulsatilla saccharomyces cerevisiae rna saccharomyces cerevisiae rna schoenocaulon officinale seed schoenocaulon officinale seed teucrium scorodonia flowering top teucrium scorodonia flowering top ascorbic acid citric acid monohydrate citrus aurantium fruit oil orange peel citrus reticulata fruit oil water glycerin lactic acid, unspecified form lonicera japonica flower benzylpenicilloyl polylysine carya ovata bark steviol

Indications and 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 â 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

Warnings:

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

Dosage and Administration:

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

Package Label Principal Display Panel:

Image description great lakes us.jpg

Comments/ Reviews:

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