Seasonal Allergy Formula

Hydrastis Canadensis, Kali Muriaticum, Gelsemium Sempervirens, Kali Bichromicum, Sabadilla, Histaminum, House Dust, Grass Mix, Trees Mix, Weeds Mix


Integrative Healing Institute, Llc
Human Otc Drug
NDC 59623-001
Seasonal Allergy Formula also known as Hydrastis Canadensis, Kali Muriaticum, Gelsemium Sempervirens, Kali Bichromicum, Sabadilla, Histaminum, House Dust, Grass Mix, Trees Mix, Weeds Mix is a human otc drug labeled by 'Integrative Healing Institute, Llc'. National Drug Code (NDC) number for Seasonal Allergy Formula is 59623-001. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Seasonal Allergy Formula drug includes Acer Negundo Pollen - 6 [hp_X]/mL Acer Rubrum Pollen - 6 [hp_X]/mL Acer Saccharinum Pollen - 6 [hp_X]/mL Acer Saccharum Pollen - 6 [hp_X]/mL Alnus Rubra Pollen - 6 [hp_X]/mL Amaranthus Retroflexus Pollen - 6 [hp_X]/mL Ambrosia Artemisiifolia Pollen - 6 [hp_X]/mL Anthoxanthum Odoratum - 6 [hp_X]/mL Artemisia Vulgaris Pollen - 6 [hp_X]/mL Barley - 6 [hp_X]/mL and more. The currest status of Seasonal Allergy Formula drug is Active.

Drug Information:

Drug NDC: 59623-001
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: Seasonal Allergy Formula
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: Hydrastis Canadensis, Kali Muriaticum, Gelsemium Sempervirens, Kali Bichromicum, Sabadilla, Histaminum, House Dust, Grass Mix, Trees Mix, Weeds Mix
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Integrative Healing Institute, Llc
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:ACER NEGUNDO POLLEN - 6 [hp_X]/mL
ACER RUBRUM POLLEN - 6 [hp_X]/mL
ACER SACCHARINUM POLLEN - 6 [hp_X]/mL
ACER SACCHARUM POLLEN - 6 [hp_X]/mL
ALNUS RUBRA POLLEN - 6 [hp_X]/mL
AMARANTHUS RETROFLEXUS POLLEN - 6 [hp_X]/mL
AMBROSIA ARTEMISIIFOLIA POLLEN - 6 [hp_X]/mL
ANTHOXANTHUM ODORATUM - 6 [hp_X]/mL
ARTEMISIA VULGARIS POLLEN - 6 [hp_X]/mL
BARLEY - 6 [hp_X]/mL
BETULA LENTA POLLEN - 6 [hp_X]/mL
BETULA NIGRA POLLEN - 6 [hp_X]/mL
BETULA PAPYRIFERA POLLEN - 6 [hp_X]/mL
BETULA PUBESCENS FLOWER BUD - 6 [hp_X]/mL
BROMUS SECALINUS POLLEN - 6 [hp_X]/mL
CARYA ALBA POLLEN - 6 [hp_X]/mL
CARYA GLABRA POLLEN - 6 [hp_X]/mL
CARYA LACINIOSA POLLEN - 6 [hp_X]/mL
CARYA OVATA POLLEN - 6 [hp_X]/mL
CYNODON DACTYLON POLLEN - 6 [hp_X]/mL
FRAXINUS AMERICANA POLLEN - 6 [hp_X]/mL
FRAXINUS PENNSYLVANICA POLLEN - 6 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT - 12 [hp_C]/mL
GOLDENSEAL - 4 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE - 30 [hp_C]/mL
HOUSE DUST - 12 [hp_X]/mL
JUGLANS REGIA POLLEN - 6 [hp_X]/mL
JUNIPERUS VIRGINIANA POLLEN - 6 [hp_X]/mL
MELILOTUS OFFICINALIS TOP - 6 [hp_X]/mL
MORUS RUBRA POLLEN - 6 [hp_X]/mL
PHLEUM PRATENSE TOP - 6 [hp_X]/mL
PINUS NIGRA POLLEN - 6 [hp_X]/mL
PINUS STROBUS POLLEN - 6 [hp_X]/mL
PINUS SYLVESTRIS POLLEN - 6 [hp_X]/mL
PINUS TAEDA POLLEN - 6 [hp_X]/mL
PLANTAGO LANCEOLATA POLLEN - 6 [hp_X]/mL
PLATANUS OCCIDENTALIS POLLEN - 6 [hp_X]/mL
POA PRATENSIS POLLEN - 6 [hp_X]/mL
POPULUS ALBA POLLEN - 6 [hp_X]/mL
POTASSIUM CHLORIDE - 6 [hp_X]/mL
POTASSIUM DICHROMATE - 12 [hp_C]/mL
QUERCUS ALBA POLLEN - 6 [hp_X]/mL
QUERCUS MACROCARPA POLLEN - 6 [hp_X]/mL
QUERCUS MARILANDICA POLLEN - 6 [hp_X]/mL
QUERCUS RUBRA POLLEN - 6 [hp_X]/mL
QUERCUS STELLATA POLLEN - 6 [hp_X]/mL
RUMEX ACETOSELLA POLLEN - 6 [hp_X]/mL
SCHOENOCAULON OFFICINALE SEED - 12 [hp_C]/mL
SOLIDAGO VIRGAUREA POLLEN - 6 [hp_X]/mL
SORGHUM HALEPENSE POLLEN - 6 [hp_X]/mL
TRITICUM AESTIVUM POLLEN - 6 [hp_X]/mL
ULMUS AMERICANA POLLEN - 6 [hp_X]/mL
ULMUS PUMILA POLLEN - 6 [hp_X]/mL
ULMUS RUBRA POLLEN - 6 [hp_X]/mL
ZEA MAYS POLLEN - 6 [hp_X]/mL
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: 22 Jul, 2013
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:Integrative Healing Institute, LLC
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:N0000185367
N0000175629
N0000184306
N0000185001
M0017130
M0000728
N0000185006
N0000185371
M0006342
N0000185016
N0000185374
M0006896
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:P6K070AR8V
700NK45C76
95447163DG
V38QUQ7861
Z0F2YK1B7H
73B14PX5FW
K20Y81ACO3
YMW1K70E4Q
ANT994T71D
5PWM7YLI7R
JQ5HI5004M
93963RFO1P
3538FNV8AY
32JS91VU1G
Q4T1SJ3046
G2A764T54B
KPO1Z9N98A
5BGG872373
54UN9R2798
175F461W10
G684LX721Q
2WZG2G15WX
639KR60Q1Q
ZW3Z11D0JV
3POA0Q644U
EYO007VX98
ARW43087I1
PY0JA16R2G
GM6P02J2DX
9LYI4RTZ52
S7PW24BX20
17Q05812N1
TX1ER5UV3T
59070I8M63
4O1FFR8ARN
DO87T1U2CI
E03U1K03LK
SCB8J7LS3T
VU8C8SB23P
660YQ98I10
T4423S18FM
Z4Y9ZSV4KK
57BTU4547U
ZTR043UHDE
SVW19ET93C
W34X0P8636
N52MIQ81ZW
6NAF1689IO
77K87U8X7J
577VA5B4HP
F1KAH8374D
89BAT511BD
030R993R8E
GHC6OHK0W0
74PD8J616H
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 Pollen Allergenic Extract [EPC]
Standardized Pollen Allergenic Extract [EPC]
Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized House Dust 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]
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:Pollen [CS]
Allergens [CS]
Dietary Proteins [CS]
House Dust [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:Allergens [CS]
Cell-mediated Immunity [PE]
Dietary Proteins [CS]
Grain Proteins [EXT]
House Dust [CS]
Increased Histamine Release [PE]
Increased IgG Production [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
59623-001-0130 mL in 1 BOTTLE, DROPPER (59623-001-01)22 Jul, 2013N/ANo
59623-001-0259 mL in 1 BOTTLE, DROPPER (59623-001-02)22 Jul, 2013N/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:

Purpose: relief from sinus congestion, runny nose, itchy eyes, and sneezing.

Product Elements:

Seasonal allergy formula hydrastis canadensis, kali muriaticum, gelsemium sempervirens, kali bichromicum, sabadilla, histaminum, house dust, grass mix, trees mix, weeds mix citric acid monohydrate potassium sorbate water goldenseal goldenseal potassium chloride potassium cation gelsemium sempervirens root gelsemium sempervirens root potassium dichromate dichromate ion schoenocaulon officinale seed schoenocaulon officinale seed histamine dihydrochloride histamine house dust house dust anthoxanthum odoratum anthoxanthum odoratum bromus secalinus pollen bromus secalinus pollen cynodon dactylon pollen cynodon dactylon pollen barley barley sorghum halepense pollen sorghum halepense pollen poa pratensis pollen poa pratensis pollen melilotus officinalis top melilotus officinalis top phleum pratense top phleum pratense top triticum aestivum pollen triticum aestivum pollen zea mays pollen zea mays pollen amaranthus retroflexus pollen amaranthus retroflexus pollen ambrosia artemisiifolia pollen ambrosia artemisiifolia pollen rumex acetosella pollen rumex acetosella pollen solidago virgaurea pollen solidago virgaurea pollen artemisia vulgaris pollen artemisia vulgaris pollen alnus rubra pollen alnus rubra pollen fraxinus pennsylvanica pollen fraxinus pennsylvanica pollen fraxinus americana pollen fraxinus americana pollen betula papyrifera pollen betula papyrifera pollen betula nigra pollen betula nigra pollen betula lenta pollen betula lenta pollen betula pubescens flower bud betula pubescens flower bud acer negundo pollen acer negundo pollen ulmus americana pollen ulmus americana pollen ulmus pumila pollen ulmus pumila pollen ulmus rubra pollen ulmus rubra pollen carya glabra pollen carya glabra pollen carya ovata pollen carya ovata pollen carya laciniosa pollen carya laciniosa pollen carya alba pollen carya alba pollen acer rubrum pollen acer rubrum pollen acer saccharinum pollen acer saccharinum pollen acer saccharum pollen acer saccharum pollen quercus marilandica pollen quercus marilandica pollen quercus macrocarpa pollen quercus macrocarpa pollen quercus stellata pollen quercus stellata pollen quercus rubra pollen quercus rubra pollen quercus alba pollen quercus alba pollen pinus nigra pollen pinus nigra pollen pinus taeda pollen pinus taeda pollen pinus sylvestris pollen pinus sylvestris pollen pinus strobus pollen pinus strobus pollen morus rubra pollen morus rubra pollen juniperus virginiana pollen juniperus virginiana pollen platanus occidentalis pollen platanus occidentalis pollen juglans regia pollen juglans regia pollen populus alba pollen populus alba pollen plantago lanceolata pollen plantago lanceolata pollen

Indications and Usage:

Use: this product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.

Warnings:

Warnings: use only as directed. stop use and consult a doctor if symptoms worsen or do not improve after 5 days. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children.

Dosage and Administration:

Directions: shake bottle well before use. adults (12 and older) take 6-10 drops orally (in water if desired) 1-3 times a day as needed. children (11 and younger) take 4 - 6 drops orally 1-3 times a day as needed or as directed by your health care provider. consult a physician for use in children under 12 years of age.

Package Label Principal Display Panel:

Integrative healing institute ® homeopathic medicine ndc: 59623-001-01 ndc: 59623-001-02 seasonal allergy formula safe natural effective alcohol free net 1 fl oz (30 ml) net 2 fl oz (59 ml) 1oz bottle label 2oz bottle label purpose: relief from sinus congestion, runny nose, itchy eyes, and sneezing.

Further Questions:

Integrative healing institute ® san antonio, tx 78216 integrativehealingsa.com questions? call 1.888.841.4034


Comments/ Reviews:

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