Regional Allergies Plains U.s.

Absinthium, Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium Cepa, Ambrosia Artemisiaefolia, Arum Triphyllum, Arundo Mauritanica, Caulophyllum Thalictroides, Conium Maculatum, Cortisone Aceticum, Euphrasia Officinalis, Fagopyrum Esculentum, Galphimia Glauca, Histaminum Hydrochloricum, Kali Muriaticum, Melilotus Officinalis, Natrum Muriaticum, Rna, Rumex Crispus, Sabadilla, Secale Cornutum


King Bio Inc.
Human Otc Drug
NDC 57955-2810
Regional Allergies Plains U.s. also known as Absinthium, Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium Cepa, Ambrosia Artemisiaefolia, Arum Triphyllum, Arundo Mauritanica, Caulophyllum Thalictroides, Conium Maculatum, Cortisone Aceticum, Euphrasia Officinalis, Fagopyrum Esculentum, Galphimia Glauca, Histaminum Hydrochloricum, Kali Muriaticum, Melilotus Officinalis, Natrum Muriaticum, Rna, Rumex Crispus, Sabadilla, Secale Cornutum is a human otc drug labeled by 'King Bio Inc.'. National Drug Code (NDC) number for Regional Allergies Plains U.s. is 57955-2810. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Regional Allergies Plains 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 Caulophyllum Thalictroides Root - 12 [hp_X]/59mL Claviceps Purpurea Sclerotium - 12 [hp_X]/59mL Conium Maculatum Flowering Top - 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 Plains U.s. drug is Active.

Drug Information:

Drug NDC: 57955-2810
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 Plains 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: Absinthium, Adenosinum Cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium Cepa, Ambrosia Artemisiaefolia, Arum Triphyllum, Arundo Mauritanica, Caulophyllum Thalictroides, Conium Maculatum, Cortisone Aceticum, Euphrasia Officinalis, Fagopyrum Esculentum, Galphimia Glauca, Histaminum Hydrochloricum, Kali Muriaticum, Melilotus Officinalis, Natrum Muriaticum, Rna, Rumex Crispus, Sabadilla, Secale Cornutum
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
CAULOPHYLLUM THALICTROIDES ROOT - 12 [hp_X]/59mL
CLAVICEPS PURPUREA SCLEROTIUM - 12 [hp_X]/59mL
CONIUM MACULATUM FLOWERING TOP - 12 [hp_X]/59mL
CORTICOTROPIN - 30 [hp_X]/59mL
CORTISONE ACETATE - 12 [hp_X]/59mL
EPINEPHRINE - 12 [hp_X]/59mL
EUPHRASIA STRICTA - 12 [hp_X]/59mL
FAGOPYRUM ESCULENTUM WHOLE - 12 [hp_X]/59mL
GALPHIMIA GLAUCA FLOWERING TOP - 12 [hp_X]/59mL
HISTAMINE DIHYDROCHLORIDE - 12 [hp_X]/59mL
MELILOTUS OFFICINALIS TOP - 12 [hp_X]/59mL
ONION - 12 [hp_X]/59mL
POTASSIUM CHLORIDE - 12 [hp_X]/59mL
RUMEX CRISPUS ROOT - 12 [hp_X]/59mL
SACCHAROMYCES CEREVISIAE RNA - 12 [hp_X]/59mL
SCHOENOCAULON OFFICINALE SEED - 12 [hp_X]/59mL
SODIUM CHLORIDE - 12 [hp_X]/59mL
WORMWOOD - 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: 11 Apr, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 05 May, 2026
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
JTJ6HH6YEH
01G9XEA93N
Q28R5GF371
K0U68Q2TXA
883WKN7W8X
YKH834O4BH
C9642I91WL
B10M69172N
93PH5Q8M7E
3POA0Q644U
GM6P02J2DX
492225Q21H
660YQ98I10
9N1RM2S62C
J17GBZ5VGX
6NAF1689IO
451W47IQ8X
F84709P2XV
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
57955-2810-21 BOTTLE, SPRAY in 1 CARTON (57955-2810-2) / 59 mL in 1 BOTTLE, SPRAY11 Apr, 2022N/ANo
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.

Purpose:

Absinthium................................................itchy eyes, sore throat 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 caulophyllum thalictroides ...............hoarseness, panting breath conium maculatum ............. sick headache, shortness of breath cortisone aceticum.............................allergic reaction, irritability euphrasia officinalis.....................discharge from eyes and nose fagopyrum esculentum................... red, itching eyes, headache galphimia glauca................................ swollen eyelids, hay fever histaminum hydrochloricum ............. coughing fits, itching throat kali muriaticum....................hoarseness, stuffy nose, nosebleed melilotus officinalis................... congestive headache, dry cough natrum muriaticum ...................................watery eyes, sneezing rna .................................................................. allergic reactions rumex crispus...............raw throat with much mucus, dry cough sabadilla........................... sore throat, runny nose, sneezing fits secale cornutum ........................pain in lungs, difficult breathing reference image: plains.jpg

Product Elements:

Regional allergies plains u.s. absinthium, adenosinum cyclophosphoricum, adrenalinum, adrenocorticotrophin, allium cepa, ambrosia artemisiaefolia, arum triphyllum, arundo mauritanica, caulophyllum thalictroides, conium maculatum, cortisone aceticum, euphrasia officinalis, fagopyrum esculentum, galphimia glauca, histaminum hydrochloricum, kali muriaticum, melilotus officinalis, natrum muriaticum, rna, rumex crispus, sabadilla, secale cornutum wormwood wormwood 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 caulophyllum thalictroides root caulophyllum thalictroides root conium maculatum flowering top conium maculatum flowering top cortisone acetate cortisone euphrasia stricta euphrasia stricta fagopyrum esculentum whole fagopyrum esculentum galphimia glauca flowering top galphimia glauca flowering top histamine dihydrochloride histamine potassium chloride potassium cation melilotus officinalis top melilotus officinalis top sodium chloride chloride ion saccharomyces cerevisiae rna saccharomyces cerevisiae rna rumex crispus root rumex crispus root schoenocaulon officinale seed schoenocaulon officinale seed claviceps purpurea sclerotium claviceps purpurea sclerotium 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 ofallergy symptoms commonly experienced in ks, nd, ne, sd: 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: plains.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: plains.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: plains.jpg

Package Label Principal Display Panel:

Image description plains.jpg


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.