Texaclear Homeopathic Allergy Relief Kids Cedar Fever

Over 100 Extracts


Gm Pharmaceuticals, Inc
Human Otc Drug
NDC 58809-207
Texaclear Homeopathic Allergy Relief Kids Cedar Fever also known as Over 100 Extracts is a human otc drug labeled by 'Gm Pharmaceuticals, Inc'. National Drug Code (NDC) number for Texaclear Homeopathic Allergy Relief Kids Cedar Fever is 58809-207. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Texaclear Homeopathic Allergy Relief Kids Cedar Fever drug includes Acacia Pollen - 30 [hp_X]/mL Acer Negundo Pollen - 30 [hp_X]/mL Acer Rubrum Pollen - 30 [hp_X]/mL Acer Saccharinum Pollen - 30 [hp_X]/mL Acer Saccharum Pollen - 30 [hp_X]/mL Agrostis Gigantea Pollen - 30 [hp_X]/mL Allenrolfea Occidentalis Pollen - 30 [hp_X]/mL Alnus Rhombifolia Pollen - 30 [hp_X]/mL Amaranthus Hybridus Pollen - 30 [hp_X]/mL Amaranthus Palmeri Pollen - 30 [hp_X]/mL and more. The currest status of Texaclear Homeopathic Allergy Relief Kids Cedar Fever drug is Active.

Drug Information:

Drug NDC: 58809-207
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: Texaclear Homeopathic Allergy Relief Kids Cedar Fever
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Texaclear Homeopathic Allergy Relief
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: Kids Cedar Fever
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: Over 100 Extracts
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Gm Pharmaceuticals, Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Solution/ Drops
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 POLLEN - 30 [hp_X]/mL
ACER NEGUNDO POLLEN - 30 [hp_X]/mL
ACER RUBRUM POLLEN - 30 [hp_X]/mL
ACER SACCHARINUM POLLEN - 30 [hp_X]/mL
ACER SACCHARUM POLLEN - 30 [hp_X]/mL
AGROSTIS GIGANTEA POLLEN - 30 [hp_X]/mL
ALLENROLFEA OCCIDENTALIS POLLEN - 30 [hp_X]/mL
ALNUS RHOMBIFOLIA POLLEN - 30 [hp_X]/mL
AMARANTHUS HYBRIDUS POLLEN - 30 [hp_X]/mL
AMARANTHUS PALMERI POLLEN - 30 [hp_X]/mL
AMARANTHUS RETROFLEXUS POLLEN - 30 [hp_X]/mL
AMARANTHUS SPINOSUS POLLEN - 30 [hp_X]/mL
AMARANTHUS TUBERCULATUS POLLEN - 30 [hp_X]/mL
AMBROSIA ACANTHICARPA POLLEN - 30 [hp_X]/mL
AMBROSIA BIDENTATA POLLEN - 30 [hp_X]/mL
AMBROSIA CONFERTIFLORA POLLEN - 30 [hp_X]/mL
AMBROSIA DUMOSA POLLEN - 30 [hp_X]/mL
AMBROSIA PSILOSTACHYA POLLEN - 30 [hp_X]/mL
AMBROSIA TRIFIDA POLLEN - 30 [hp_X]/mL
ARTEMISIA ANNUA POLLEN - 30 [hp_X]/mL
ARTEMISIA TRIDENTATA POLLEN - 30 [hp_X]/mL
ARTEMISIA VULGARIS WHOLE - 30 [hp_X]/mL
ATRIPLEX CANESCENS POLLEN - 30 [hp_X]/mL
BACCHARIS HALIMIFOLIA WHOLE - 30 [hp_X]/mL
BAPTISIA TINCTORIA ROOT - 6 [hp_X]/mL
BASSIA SCOPARIA POLLEN - 30 [hp_X]/mL
BETULA LENTA POLLEN - 30 [hp_X]/mL
BETULA OCCIDENTALIS WHOLE - 30 [hp_X]/mL
BROMUS INERMIS POLLEN - 30 [hp_X]/mL
BROUSSONETIA PAPYRIFERA POLLEN - 30 [hp_X]/mL
CARYA CORDIFORMIS WHOLE - 30 [hp_X]/mL
CARYA GLABRA POLLEN - 30 [hp_X]/mL
CARYA ILLINOINENSIS POLLEN - 30 [hp_X]/mL
CARYA LACINIOSA POLLEN - 30 [hp_X]/mL
CARYA OVATA POLLEN - 30 [hp_X]/mL
CHENOPODIUM ALBUM POLLEN - 30 [hp_X]/mL
CUPRESSUS ARIZONICA POLLEN - 30 [hp_X]/mL
CYCLACHAENA XANTHIFOLIA POLLEN - 30 [hp_X]/mL
DACTYLIS GLOMERATA POLLEN - 30 [hp_X]/mL
DISTICHLIS SPICATA POLLEN - 30 [hp_X]/mL
ECHINACEA, UNSPECIFIED - 6 [hp_X]/mL
ELYMUS REPENS POLLEN - 30 [hp_X]/mL
FAGUS GRANDIFOLIA POLLEN - 30 [hp_X]/mL
FESTUCA PRATENSIS POLLEN - 30 [hp_X]/mL
FRAXINUS AMERICANA POLLEN - 30 [hp_X]/mL
FRAXINUS PENNSYLVANICA POLLEN - 30 [hp_X]/mL
FRAXINUS VELUTINA POLLEN - 30 [hp_X]/mL
GUTIERREZIA SAROTHRAE WHOLE - 30 [hp_X]/mL
HYDRASTIS CANADENSIS WHOLE - 6 [hp_X]/mL
IVA ANNUA POLLEN - 30 [hp_X]/mL
JUGLANS NIGRA POLLEN - 30 [hp_X]/mL
JUNIPER BERRY - 30 [hp_X]/mL
JUNIPERUS DEPPEANA WHOLE - 30 [hp_X]/mL
JUNIPERUS OSTEOSPERMA POLLEN - 30 [hp_X]/mL
JUNIPERUS SCOPULORUM POLLEN - 30 [hp_X]/mL
JUNIPERUS VIRGINIANA POLLEN - 30 [hp_X]/mL
LIGUSTRUM LUCIDUM WHOLE - 30 [hp_X]/mL
LIQUIDAMBAR STYRACIFLUA POLLEN - 30 [hp_X]/mL
LOLIUM MULTIFLORUM POLLEN - 30 [hp_X]/mL
LOLIUM PERENNE POLLEN - 30 [hp_X]/mL
MELALEUCA QUINQUENERVIA POLLEN - 30 [hp_X]/mL
MORUS ALBA WHOLE - 30 [hp_X]/mL
MORUS RUBRA POLLEN - 30 [hp_X]/mL
MYRRH - 6 [hp_X]/mL
PASCOPYRUM SMITHII POLLEN - 30 [hp_X]/mL
PHALARIS ARUNDINACEA POLLEN - 30 [hp_X]/mL
PHLEUM PRATENSE POLLEN - 30 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT - 6 [hp_X]/mL
PINUS PONDEROSA POLLEN - 30 [hp_X]/mL
PINUS STROBUS POLLEN - 30 [hp_X]/mL
PINUS TAEDA POLLEN - 30 [hp_X]/mL
PLANTAGO LANCEOLATA POLLEN - 30 [hp_X]/mL
PLATANUS OCCIDENTALIS POLLEN - 30 [hp_X]/mL
POPULUS ALBA POLLEN - 30 [hp_X]/mL
POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN - 30 [hp_X]/mL
POPULUS FREMONTII POLLEN - 30 [hp_X]/mL
POPULUS NIGRA POLLEN - 30 [hp_X]/mL
QUERCUS ALBA WHOLE - 30 [hp_X]/mL
QUERCUS GAMBELII POLLEN - 30 [hp_X]/mL
QUERCUS MACROCARPA POLLEN - 30 [hp_X]/mL
QUERCUS NIGRA POLLEN - 30 [hp_X]/mL
QUERCUS RUBRA BARK - 30 [hp_X]/mL
QUERCUS STELLATA POLLEN - 30 [hp_X]/mL
QUERCUS VELUTINA WHOLE - 30 [hp_X]/mL
RUMEX ACETOSELLA POLLEN - 30 [hp_X]/mL
RUMEX CRISPUS POLLEN - 30 [hp_X]/mL
SALSOLA KALI WHOLE - 30 [hp_X]/mL
SECALE CEREALE POLLEN - 30 [hp_X]/mL
SOLIDAGO CANADENSIS WHOLE - 30 [hp_X]/mL
SORGHUM HALEPENSE POLLEN - 30 [hp_X]/mL
TAXODIUM DISTICHUM POLLEN - 30 [hp_X]/mL
THUJA OCCIDENTALIS LEAF - 30 [hp_X]/mL
THUJA PLICATA LEAF - 30 [hp_X]/mL
TRIADICA SEBIFERA WHOLE - 30 [hp_X]/mL
TRITICUM AESTIVUM POLLEN - 30 [hp_X]/mL
ULMUS AMERICANA POLLEN - 30 [hp_X]/mL
ULMUS CRASSIFOLIA POLLEN - 30 [hp_X]/mL
ULMUS PUMILA POLLEN - 30 [hp_X]/mL
URTICA DIOICA POLLEN - 30 [hp_X]/mL
XANTHIUM STRUMARIUM POLLEN - 30 [hp_X]/mL
ZEA MAYS POLLEN - 30 [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: 21 Aug, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 10 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:GM Pharmaceuticals, 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.
UPC:0358809207305
UPC stands for Universal Product Code.
NUI:N0000185367
N0000175629
N0000184306
N0000185001
M0017130
M0000728
N0000185006
N0000185371
N0000185375
M0006342
M0016962
M0008672
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:43DDR2YDYZ
P6K070AR8V
700NK45C76
95447163DG
V38QUQ7861
HU8V6E7HOA
5W6JAI84OI
7X8HL8GRTM
EK7F0414PI
1GH3WV23KH
73B14PX5FW
380W4HYR6N
92N6W6KO2G
U2AI3H2J5Y
M3S672G75O
63TBJ590BL
ZIO18VN6HJ
RX18M46K8L
KU1V1898XX
36R82U4DL6
YI19RB8YFD
JDR81QW9ZQ
26U0BU8G83
2CV09XA44X
5EF0HWI5WU
07A108ZKW5
JQ5HI5004M
NPA6EIU3QB
766QT72BK6
51I6N3XIML
MP18902J3H
KPO1Z9N98A
PYO4JR720Y
5BGG872373
54UN9R2798
098LKX5NCN
232DMH0XVF
V80TPZ0T6J
83N78IDA7P
GOA51670YV
4N9P6CC1DX
ON2T85TA2O
34X886W1H4
A0WFQ8P6N1
G684LX721Q
2WZG2G15WX
LJT6I6Z8FD
4Y008TDX2F
R763EBH88T
Y2U5S5PF22
1BV28146ZR
O84B5194RL
7XR372977U
15L060HV8H
0G82TT8ZFY
PY0JA16R2G
8AA7186XEP
5Q246DS5BS
VJI0WKK736
4T81LB52R0
NX974IRT8E
C4228R0MX2
9LYI4RTZ52
JC71GJ1F3L
6AU0ZD8T1O
FAY1Y90VJ9
65M88RW2EG
11E6VI8VEG
042SUA2DS9
TX1ER5UV3T
4O1FFR8ARN
DO87T1U2CI
E03U1K03LK
VU8C8SB23P
476DVV63WP
426RHB4302
0MGE63QPFJ
8160EU25B5
9HC15X34LX
57BTU4547U
6U600U1326
X26K8566JX
W34X0P8636
3NQP837A96
N52MIQ81ZW
V825XJG64G
0BKP293XE9
I6KAZ8AO1O
OLL328076K
577VA5B4HP
O12H03B41R
0T0DQN8786
R9I752FESH
9166K7Q8MX
F1KAH8374D
89BAT511BD
G82398SD3I
030R993R8E
DNB59M1NVU
2QOF601J1M
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 Plant 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]
Plant Proteins [CS]
Food Additives [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]
Food Additives [CS]
Increased Histamine Release [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
58809-207-3030 mL in 1 BOTTLE, DROPPER (58809-207-30)21 Aug, 2020N/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 sneezing, runny nose, itchy eyes and sinus congestion.*

Product Elements:

Texaclear homeopathic allergy relief kids cedar fever over 100 extracts thuja plicata leaf thuja plicata leaf xylitol baptisia tinctoria root baptisia tinctoria root baccharis halimifolia whole baccharis halimifolia whole lolium perenne pollen lolium perenne pollen glycerin water stevia leaf betula lenta pollen betula lenta pollen fraxinus americana pollen fraxinus americana pollen hydrastis canadensis whole hydrastis canadensis whole myrrh myrrh phytolacca americana root phytolacca americana root echinacea, unspecified echinacea, unspecified elymus repens pollen elymus repens pollen festuca pratensis pollen festuca pratensis pollen sorghum halepense pollen sorghum halepense pollen dactylis glomerata pollen dactylis glomerata pollen phleum pratense pollen phleum pratense pollen triticum aestivum pollen triticum aestivum pollen phalaris arundinacea pollen phalaris arundinacea pollen zea mays pollen zea mays pollen secale cereale pollen secale cereale pollen fraxinus velutina pollen fraxinus velutina pollen lolium multiflorum pollen lolium multiflorum pollen artemisia tridentata pollen artemisia tridentata pollen acacia pollen acacia pollen fraxinus pennsylvanica pollen fraxinus pennsylvanica pollen juniperus virginiana pollen juniperus virginiana pollen populus deltoides subsp. deltoides pollen populus deltoides subsp. deltoides pollen cupressus arizonica pollen cupressus arizonica pollen taxodium distichum pollen taxodium distichum pollen ulmus americana pollen ulmus americana pollen ulmus crassifolia pollen ulmus crassifolia pollen ulmus pumila pollen ulmus pumila pollen platanus occidentalis pollen platanus occidentalis pollen bromus inermis pollen bromus inermis pollen distichlis spicata pollen distichlis spicata pollen acer saccharum pollen acer saccharum pollen broussonetia papyrifera pollen broussonetia papyrifera pollen morus rubra pollen morus rubra pollen carya illinoinensis pollen carya illinoinensis pollen pinus taeda pollen pinus taeda pollen populus alba pollen populus alba pollen liquidambar styraciflua pollen liquidambar styraciflua pollen juglans nigra pollen juglans nigra pollen triadica sebifera whole triadica sebifera whole quercus rubra bark quercus rubra bark quercus macrocarpa pollen quercus macrocarpa pollen quercus stellata pollen quercus stellata pollen populus nigra pollen populus nigra pollen betula occidentalis whole betula occidentalis whole carya cordiformis whole carya cordiformis whole juniperus deppeana whole juniperus deppeana whole ligustrum lucidum whole ligustrum lucidum whole morus alba whole morus alba whole quercus alba whole quercus alba whole fagus grandifolia pollen fagus grandifolia pollen carya glabra pollen carya glabra pollen carya ovata pollen carya ovata pollen carya laciniosa pollen carya laciniosa pollen melaleuca quinquenervia pollen melaleuca quinquenervia pollen thuja occidentalis leaf thuja occidentalis leaf quercus nigra pollen quercus nigra pollen pinus strobus pollen pinus strobus pollen populus fremontii pollen populus fremontii pollen pinus ponderosa pollen pinus ponderosa pollen quercus gambelii pollen quercus gambelii pollen juniperus osteosperma pollen juniperus osteosperma pollen juniperus scopulorum pollen juniperus scopulorum pollen artemisia vulgaris whole artemisia vulgaris whole gutierrezia sarothrae whole gutierrezia sarothrae whole ambrosia acanthicarpa pollen ambrosia acanthicarpa pollen salsola kali whole salsola kali whole amaranthus tuberculatus pollen amaranthus tuberculatus pollen atriplex canescens pollen atriplex canescens pollen artemisia annua pollen artemisia annua pollen amaranthus palmeri pollen amaranthus palmeri pollen ambrosia trifida pollen ambrosia trifida pollen ambrosia confertiflora pollen ambrosia confertiflora pollen ambrosia bidentata pollen ambrosia bidentata pollen ambrosia psilostachya pollen ambrosia psilostachya pollen quercus velutina whole quercus velutina whole rumex crispus pollen rumex crispus pollen agrostis gigantea pollen agrostis gigantea pollen bassia scoparia pollen bassia scoparia pollen amaranthus hybridus pollen amaranthus hybridus pollen xanthium strumarium pollen xanthium strumarium pollen rumex acetosella pollen rumex acetosella pollen solidago canadensis whole solidago canadensis whole chenopodium album pollen chenopodium album pollen cyclachaena xanthifolia pollen cyclachaena xanthifolia pollen urtica dioica pollen urtica dioica pollen amaranthus spinosus pollen amaranthus spinosus pollen amaranthus retroflexus pollen amaranthus retroflexus pollen plantago lanceolata pollen plantago lanceolata pollen allenrolfea occidentalis pollen allenrolfea occidentalis pollen ambrosia dumosa pollen ambrosia dumosa pollen acer negundo pollen acer negundo pollen acer rubrum pollen acer rubrum pollen acer saccharinum pollen acer saccharinum pollen pascopyrum smithii pollen pascopyrum smithii pollen alnus rhombifolia pollen alnus rhombifolia pollen juniper berry juniper berry iva annua pollen iva annua pollen

Indications and Usage:

Uses : 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. for oral (sublingual use.) stop use and ask a doctor if symptoms worsen or do not improve after 7 days. if pregnant or breast-feeding , consult a health professional before use. keep out of reach of children . if swallowed, get medical help or contact a poison control center right away.

Dosage and Administration:

Directions ■ measure only with enclosed dropper provided ■ children 2 to under 12 years: 6-10 drops under the tongue three times daily or as directed by a doctor. ■ consult a doctor for use in children under 2 years of age.

Stop Use:

Stop use and ask a doctor if symptoms worsen or do not improve after 7 days.

Package Label Principal Display Panel:

Principal display panel principal display panel ndc 58809-209-30 texaclear homeoapthic allergy relief net 1fl oz (30 ml) pdp1

Further Questions:

Questions? 1-888-535-0305 or visit www.texaclear.com


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.