Southeast Regional 1024

Southeast Regional

Professional Complementary Health Formulas
Human Otc Drug
NDC 63083-1024

Southeast Regional 1024 also known as Southeast Regional is a human otc drug labeled by 'Professional Complementary Health Formulas'. National Drug Code (NDC) number for Southeast Regional 1024 is 63083-1024. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Southeast Regional 1024 drug includes Acacia - 6 [hp_X]/59mL Amaranthus Hybridus Leaf - 6 [hp_X]/59mL Amaranthus Tuberculatus Pollen - 6 [hp_X]/59mL Ambrosia Artemisiifolia Whole - 6 [hp_X]/59mL Beef Liver - 6 [hp_X]/59mL Betula Occidentalis Pollen - 6 [hp_X]/59mL Chenopodium Album Pollen - 6 [hp_X]/59mL Corticotropin - 6 [hp_X]/59mL Cynodon Dactylon Whole - 6 [hp_X]/59mL Elm - 6 [hp_X]/59mL and more. The currest status of Southeast Regional 1024 drug is Active.

Drug Information:

Drug NDC:	63083-1024
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:	Southeast Regional 1024
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Southeast Regional
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	1024
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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:	Southeast Regional
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Professional Complementary Health Formulas
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:	ACACIA - 6 [hp_X]/59mL AMARANTHUS HYBRIDUS LEAF - 6 [hp_X]/59mL AMARANTHUS TUBERCULATUS POLLEN - 6 [hp_X]/59mL AMBROSIA ARTEMISIIFOLIA WHOLE - 6 [hp_X]/59mL BEEF LIVER - 6 [hp_X]/59mL BETULA OCCIDENTALIS POLLEN - 6 [hp_X]/59mL CHENOPODIUM ALBUM POLLEN - 6 [hp_X]/59mL CORTICOTROPIN - 6 [hp_X]/59mL CYNODON DACTYLON WHOLE - 6 [hp_X]/59mL ELM - 6 [hp_X]/59mL Load more... ENGLISH WALNUT - 6 [hp_X]/59mL FRAXINUS AMERICANA BARK - 6 [hp_X]/59mL HISTAMINE DIHYDROCHLORIDE - 12 [hp_X]/59mL IVA ANGUSTIFOLIA WHOLE - 6 [hp_X]/59mL JUNIPERUS SCOPULORUM POLLEN - 6 [hp_X]/59mL MEDICAGO SATIVA WHOLE - 6 [hp_X]/59mL MELALEUCA VIRIDIFLORA WHOLE - 6 [hp_X]/59mL MILLETTIA PINNATA WHOLE - 6 [hp_X]/59mL PINUS PONDEROSA POLLEN - 6 [hp_X]/59mL PLANTAGO LANCEOLATA LEAF - 6 [hp_X]/59mL PLATANUS OCCIDENTALIS BARK - 6 [hp_X]/59mL POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN - 6 [hp_X]/59mL QUERCUS KELLOGGII POLLEN - 6 [hp_X]/59mL RUMEX CRISPUS ROOT - 6 [hp_X]/59mL SAGE - 6 [hp_X]/59mL SCHINUS TEREBINTHIFOLIA POLLEN - 6 [hp_X]/59mL STENOTAPHRUM SECUNDATUM WHOLE - 6 [hp_X]/59mL SUS SCROFA ADRENAL GLAND - 6 [hp_X]/59mL WHITE MULBERRY - 6 [hp_X]/59mL XANTHIUM STRUMARIUM VAR. CANADENSE POLLEN - 6 [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:	15 Aug, 1984
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	08 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:	Professional Complementary Health Formulas
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:	N0000185375 N0000175629 N0000184306 N0000185001 M0016962 M0000728 N0000185367 M0017130 N0000185371 M0006342 N0000185017 M0000499 N0000175941 N0000185019
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	5C5403N26O 07L86FJ69J 92N6W6KO2G 9W34L2CQ9A W8N8R55022 R889N2L976 098LKX5NCN K0U68Q2TXA 2Q8MR21NHK 63POE2M46Y Load more... 1V3SHR7QB7 0B24UR1O1S 3POA0Q644U 1BTG48T6EA 0G82TT8ZFY DJO934BRBD 0823G3NGQP 11R319D14O 042SUA2DS9 2YWL9J7EE8 85RMN3QGSE 476DVV63WP 02RVY6X9EC 9N1RM2S62C 065C5D077J 21MID214D4 H67S8RU85S 398IYQ16YV MN25R0HH5A 0ZK6G3W3BI
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 EPC:	Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Pollen Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Adrenocorticotropic Hormone [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] Increased IgG Production [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:	Plant Proteins [CS] Allergens [CS] Pollen [CS] Dietary Proteins [CS] Adrenocorticotropic Hormone [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:	Adrenocorticotropic Hormone [CS] Adrenocorticotropic Hormone [EPC] Allergens [CS] Allergens [Chemical/Ingredient] Cell-mediated Immunity [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Meat Proteins [EXT] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Pollen Allergenic Extract [EPC] Nut Proteins [EXT] Plant Proteins [CS] Pollen [CS] Pollen [Chemical/Ingredient]
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
63083-1024-2	59 mL in 1 BOTTLE, DROPPER (63083-1024-2)	15 Aug, 1985	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

Southeast Regional 1024

Southeast Regional

Liquid
Professional Complementary Health Formulas
NDC: 63083-1024

Purpose:

*claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

Southeast regional 1024 southeast regional sus scrofa adrenal gland sus scrofa adrenal gland corticotropin corticotropin histamine dihydrochloride histamine beef liver beef liver acacia acacia platanus occidentalis bark platanus occidentalis bark millettia pinnata whole millettia pinnata whole cynodon dactylon whole cynodon dactylon whole betula occidentalis pollen betula occidentalis pollen xanthium strumarium var. canadense pollen xanthium strumarium var. canadense pollen populus deltoides subsp. deltoides pollen populus deltoides subsp. deltoides pollen elm elm plantago lanceolata leaf plantago lanceolata leaf schinus terebinthifolia pollen schinus terebinthifolia pollen medicago sativa whole medicago sativa whole chenopodium album pollen chenopodium album pollen iva angustifolia whole iva angustifolia whole melaleuca viridiflora whole melaleuca viridiflora whole juniperus scopulorum pollen juniperus scopulorum pollen white mulberry white mulberry quercus kelloggii pollen quercus kelloggii pollen amaranthus hybridus leaf amaranthus hybridus leaf pinus ponderosa pollen pinus ponderosa pollen ambrosia artemisiifolia whole ambrosia artemisiifolia whole rumex crispus root rumex crispus root sage sage stenotaphrum secundatum whole stenotaphrum secundatum whole english walnut english walnut amaranthus tuberculatus pollen amaranthus tuberculatus pollen fraxinus americana bark fraxinus americana bark alcohol water

Indications and Usage:

Indications for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to sensitivity to common allergens of the southeastern united states.*

Warnings:

Warnings in case of overdose, get medical help or contact a poison control center right away. keep out of the reach of children. if pregnant or breastfeeding, ask a healthcare professional before use.

Dosage and Administration:

Directions place drops under tongue 30 minutes before/after meals. adults and children 12 years and over: take 10 to 15 drops up to 3 times per day. for desensitization, begin with 1 to 5 drops daily, increasing to the standard dose gradually to avoid symptom expression; after 1 to 3 months at the standard dose, decrease gradually to a maintenance dose of 10 to 15 drops weekly. consult a physician for use in children under 12 years of age.

Package Label Principal Display Panel:

Label est 1985 professional formulas complementary health southeast regional homeopathic remedy 2 fl. oz. (59 ml) label image

Further Questions:

Questions professional formulas po box 2034 lake oswego, or 97035

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.