FDA.reportPublic FDA data

TEXACLEAR HOMEOPATHIC ALLERGY RELIEF DROPS

Manufacturer
GM Pharmaceuticals, INC
Effective date
2023-11-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:20:07

Label at a glance#

ProductTexaClear Homeopathic Allergy Relief
Active ingredientECHINACEA, UNSPECIFIED, THUJA PLICATA LEAF, BAPTISIA TINCTORIA ROOT, BACCHARIS HALIMIFOLIA WHOLE, LOLIUM PERENNE POLLEN, BETULA LENTA POLLEN, FRAXINUS AMERICANA POLLEN, HYDRASTIS CANADENSIS WHOLE, MYRRH, PHYTOLACCA AMERICANA ROOT, ELYMUS REPENS POLLEN, FESTUCA PRATENSIS POLLEN, SORGHUM HALEPENSE POLLEN, DACTYLIS GLOMERATA POLLEN, PHLEUM PRATENSE POLLEN, TRITICUM AESTIVUM POLLEN, PHALARIS ARUNDINACEA POLLEN, ZEA MAYS POLLEN, SECALE CEREALE POLLEN, FRAXINUS VELUTINA POLLEN, LOLIUM MULTIFLORUM POLLEN, ARTEMISIA TRIDENTATA POLLEN, ACACIA POLLEN, FRAXINUS PENNSYLVANICA POLLEN, JUNIPERUS VIRGINIANA POLLEN, POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN, CUPRESSUS ARIZONICA POLLEN, TAXODIUM DISTICHUM POLLEN, ULMUS AMERICANA POLLEN, ULMUS CRASSIFOLIA POLLEN, ULMUS PUMILA POLLEN, PLATANUS OCCIDENTALIS POLLEN, BROMUS INERMIS POLLEN, DISTICHLIS SPICATA POLLEN, ACER SACCHARUM POLLEN, BROUSSONETIA PAPYRIFERA POLLEN, MORUS RUBRA POLLEN, CARYA ILLINOINENSIS POLLEN, PINUS TAEDA POLLEN, POPULUS ALBA POLLEN, LIQUIDAMBAR STYRACIFLUA POLLEN, JUGLANS NIGRA POLLEN, TRIADICA SEBIFERA WHOLE, QUERCUS RUBRA BARK, QUERCUS MACROCARPA POLLEN, QUERCUS STELLATA POLLEN, POPULUS NIGRA POLLEN, BETULA OCCIDENTALIS WHOLE, CARYA CORDIFORMIS WHOLE, JUNIPERUS DEPPEANA WHOLE, LIGUSTRUM LUCIDUM WHOLE, MORUS ALBA WHOLE, QUERCUS ALBA WHOLE, FAGUS GRANDIFOLIA POLLEN, CARYA GLABRA POLLEN, CARYA OVATA POLLEN, CARYA LACINIOSA POLLEN, MELALEUCA QUINQUENERVIA POLLEN, THUJA OCCIDENTALIS LEAF, QUERCUS NIGRA POLLEN, PINUS STROBUS POLLEN, POPULUS FREMONTII POLLEN, PINUS PONDEROSA POLLEN, QUERCUS GAMBELII POLLEN, JUNIPERUS OSTEOSPERMA POLLEN, JUNIPERUS SCOPULORUM POLLEN, ARTEMISIA VULGARIS WHOLE, GUTIERREZIA SAROTHRAE WHOLE, AMBROSIA ACANTHICARPA POLLEN, SALSOLA KALI WHOLE, AMARANTHUS TUBERCULATUS POLLEN, ATRIPLEX CANESCENS POLLEN, ARTEMISIA ANNUA POLLEN, AMARANTHUS PALMERI POLLEN, AMBROSIA TRIFIDA POLLEN, AMBROSIA CONFERTIFLORA POLLEN, AMBROSIA BIDENTATA POLLEN, AMBROSIA PSILOSTACHYA POLLEN, QUERCUS VELUTINA WHOLE, RUMEX CRISPUS POLLEN, AGROSTIS GIGANTEA POLLEN, BASSIA SCOPARIA POLLEN, AMARANTHUS HYBRIDUS POLLEN, XANTHIUM STRUMARIUM POLLEN, RUMEX ACETOSELLA POLLEN, SOLIDAGO CANADENSIS WHOLE, CHENOPODIUM ALBUM POLLEN, CYCLACHAENA XANTHIFOLIA POLLEN, URTICA DIOICA POLLEN, AMARANTHUS SPINOSUS POLLEN, AMARANTHUS RETROFLEXUS POLLEN, PLANTAGO LANCEOLATA POLLEN, ALLENROLFEA OCCIDENTALIS POLLEN, AMBROSIA DUMOSA POLLEN, ACER NEGUNDO POLLEN, ACER RUBRUM POLLEN, ACER SACCHARINUM POLLEN, PASCOPYRUM SMITHII POLLEN, ALNUS RHOMBIFOLIA POLLEN, JUNIPER BERRY, IVA ANNUA POLLEN
Label structure10 sections

Indications and uses

this product is a Homeopathic Dilution, formulated to support the body’s immunity for the temporary relief of allergies*

Dosage and administration

■ measure only with enclosed dropper provided Adults 12 years and older :10-15 drops,3 times per day, holdunder the tongue for atleast 30seconds before swallowing Consult a doctor for use if children under 12

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TexaClear Kids Homeopathic Allergy Relief

Active ingredients: Antigens 6X, 12X, 30X: **Zones 2,5,& 6 Grasses, **Zones 2,5,& 6 Trees, **Zones 2,5,& 6 Weeds; Herbal Drainage Remedies: Baptisia tinctoria 5X HPUS, Echinacea 5X HPUS, Hydrastis canadensis 5X HPUS, Myrrha 5X HPUS, Nasturtium aquaticum 5X HPUS, Phytolacca decandra 5X HPUS, Trigonella foenum-graecum 5X

TexaClear Kids Homeopathic Allergy Relief

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Antigens 30X: **Zones 2,5,& 6 Grasses, **Zones 2,5,& 6 Trees, **Zones 2,5,& 6 Weeds;

Herbal Drainage Remedies: Baptisia tinctoria 5X HPUS, Echinacea 5X HPUS, Hydrastis canadensis 5X HPUS, Myrrha 5X HPUS, Phytolacca decandra 5X HPUS

Purpose:

OTC - PURPOSE SECTION

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

Uses:

INDICATIONS & USAGE SECTION

this product is a Homeopathic Dilution, formulated to support the body’s immunity for the temporary relief of allergies*

Warnings

WARNINGS SECTION

Use only as directed. For oral (sublingual use.)

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms worsen or do not improve after 7 days.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

consult a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ measure only with enclosed dropper provided

Adults 12 years and older :10-15 drops,3 times per day, holdunder the tongue for atleast 30seconds before swallowing

Consult a doctor for use if children under 12

Other Information:

OTHER SAFETY INFORMATION

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

ethanol, purified water, stevia

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

princpal display labelprincpal display labelprincpal display label-2princpal display label-2PRINCIPAL DISPLAY PANEL

NDC 58809-206-30 AND 58809-206-60

TEXACLEAR

HOMEOAPTHIC

ALLERGY RELIEF DROPS

NET 0.95FL OZ (28 mL) 1.93 OZ (57 mL)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 3 · 106 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58809-20658809-206-30, 58809-206-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 104 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
2-(ETHYLTHIO)ETHANOL6091RQ1378IACT
WATER059QF0KO0RIACT
STEVIA LEAF6TC6NN0876IACT
THUJA PLICATA LEAFR9I752FESHACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BACCHARIS HALIMIFOLIA WHOLE2CV09XA44XACTIB
LOLIUM PERENNE POLLEN4T81LB52R0ACTIB
BETULA LENTA POLLENJQ5HI5004MACTIB
FRAXINUS AMERICANA POLLENG684LX721QACTIB
HYDRASTIS CANADENSIS WHOLER763EBH88TACTIB
MYRRHJC71GJ1F3LACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
ELYMUS REPENS POLLENON2T85TA2OACTIB
FESTUCA PRATENSIS POLLENA0WFQ8P6N1ACTIB
SORGHUM HALEPENSE POLLEN577VA5B4HPACTIB
DACTYLIS GLOMERATA POLLEN83N78IDA7PACTIB
PHLEUM PRATENSE POLLEN65M88RW2EGACTIB
TRITICUM AESTIVUM POLLENF1KAH8374DACTIB
PHALARIS ARUNDINACEA POLLENFAY1Y90VJ9ACTIB
ZEA MAYS POLLEN74PD8J616HACTIB
SECALE CEREALE POLLENI6KAZ8AO1OACTIB
FRAXINUS VELUTINA POLLENLJT6I6Z8FDACTIB
LOLIUM MULTIFLORUM POLLENVJI0WKK736ACTIB
ARTEMISIA TRIDENTATA POLLENYI19RB8YFDACTIB
ACACIA POLLEN43DDR2YDYZACTIB
FRAXINUS PENNSYLVANICA POLLEN2WZG2G15WXACTIB
JUNIPERUS VIRGINIANA POLLENPY0JA16R2GACTIB
POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN476DVV63WPACTIB
CUPRESSUS ARIZONICA POLLEN232DMH0XVFACTIB
TAXODIUM DISTICHUM POLLENO12H03B41RACTIB
ULMUS AMERICANA POLLEN89BAT511BDACTIB
ULMUS CRASSIFOLIA POLLENG82398SD3IACTIB
ULMUS PUMILA POLLEN030R993R8EACTIB
PLATANUS OCCIDENTALIS POLLENE03U1K03LKACTIB
BROMUS INERMIS POLLEN766QT72BK6ACTIB
DISTICHLIS SPICATA POLLENGOA51670YVACTIB
ACER SACCHARUM POLLENV38QUQ7861ACTIB
BROUSSONETIA PAPYRIFERA POLLEN51I6N3XIMLACTIB
MORUS RUBRA POLLEN9LYI4RTZ52ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0b273fe1-0b64-ec03-e063-6294a90a5ab6dfd8a6ea-1742-acfc-e053-2a95a90a584f2023-11-27WarningsExact identifier
spl id: 0b273fe1-0b64-ec03-e063-6294a90a5ab6
spl set id: dfd8a6ea-1742-acfc-e053-2a95a90a584f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.