NDC 58809-210 Texaclear Natural Allergy Relief

Antigens 6x,12x,30x

NDC Product Code 58809-210

NDC 58809-210-30

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Texaclear Natural Allergy Relief with NDC 58809-210 is a a human over the counter drug product labeled by Gm Pharmaceuticals, Inc. The generic name of Texaclear Natural Allergy Relief is antigens 6x,12x,30x. The product's dosage form is solution/ drops and is administered via oral form.

Labeler Name: Gm Pharmaceuticals, Inc

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Texaclear Natural Allergy Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BAPTISIA TINCTORIA ROOT 3 [hp_X]/mL
  • HYDRASTIS CANADENSIS WHOLE 3 [hp_X]/mL
  • MYRRH 3 [hp_X]/mL
  • RORIPPA NASTURTIUM-AQUATICUM 3 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 3 [hp_X]/mL
  • TRIGONELLA FOENUM-GRAECUM WHOLE 3 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/mL
  • CYNODON DACTYLON POLLEN 6 [hp_X]/mL
  • POA ANNUA POLLEN 6 [hp_X]/mL
  • POA PRATENSIS POLLEN 6 [hp_X]/mL
  • FESTUCA PRATENSIS POLLEN 6 [hp_X]/mL
  • SORGHUM HALEPENSE POLLEN 6 [hp_X]/mL
  • DACTYLIS GLOMERATA POLLEN 6 [hp_X]/mL
  • AGROSTIS GIGANTEA POLLEN 6 [hp_X]/mL
  • ELYMUS REPENS POLLEN 6 [hp_X]/mL
  • LOLIUM PERENNE POLLEN 6 [hp_X]/mL
  • PHLEUM PRATENSE POLLEN 6 [hp_X]/mL
  • TRITICUM AESTIVUM POLLEN 6 [hp_X]/mL
  • PHALARIS ARUNDINACEA POLLEN 6 [hp_X]/mL
  • ZEA MAYS POLLEN 6 [hp_X]/mL
  • SECALE CEREALE POLLEN 6 [hp_X]/mL
  • LOLIUM MULTIFLORUM POLLEN 6 [hp_X]/mL
  • DISTICHLIS SPICATA POLLEN 6 [hp_X]/mL
  • AVENA SATIVA POLLEN 6 [hp_X]/mL
  • PASPALUM NOTATUM POLLEN 6 [hp_X]/mL
  • ANTHOXANTHUM ODORATUM POLLEN 6 [hp_X]/mL
  • HOLCUS LANATUS POLLEN 6 [hp_X]/mL
  • ARTEMISIA TRIDENTATA POLLEN 6 [hp_X]/mL
  • BROMUS INERMIS POLLEN 6 [hp_X]/mL
  • ACACIA POLLEN 12 [hp_X]/mL
  • ALNUS INCANA SUBSP. RUGOSA POLLEN 12 [hp_X]/mL
  • FRAXINUS VELUTINA POLLEN 12 [hp_X]/mL
  • FRAXINUS PENNSYLVANICA POLLEN 12 [hp_X]/mL
  • BETULA NIGRA POLLEN 12 [hp_X]/mL
  • JUNIPERUS PINCHOTII POLLEN 12 [hp_X]/mL
  • JUNIPERUS ASHEI POLLEN 12 [hp_X]/mL
  • JUNIPERUS VIRGINIANA POLLEN 12 [hp_X]/mL
  • POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN 12 [hp_X]/mL
  • POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN 12 [hp_X]/mL
  • CUPRESSUS ARIZONICA POLLEN 12 [hp_X]/mL
  • TAXODIUM DISTICHUM POLLEN 12 [hp_X]/mL
  • ULMUS AMERICANA POLLEN 12 [hp_X]/mL
  • ULMUS CRASSIFOLIA POLLEN 12 [hp_X]/mL
  • ULMUS PUMILA POLLEN 12 [hp_X]/mL
  • CELTIS OCCIDENTALIS POLLEN 12 [hp_X]/mL
  • CARYA ALBA POLLEN 12 [hp_X]/mL
  • JUNIPERUS MONOSPERMA POLLEN 12 [hp_X]/mL
  • ACER SACCHARUM POLLEN 12 [hp_X]/mL
  • PROSOPIS PALLIDA POLLEN 12 [hp_X]/mL
  • BROUSSONETIA PAPYRIFERA POLLEN 12 [hp_X]/mL
  • MORUS RUBRA POLLEN 12 [hp_X]/mL
  • QUERCUS VIRGINIANA POLLEN 12 [hp_X]/mL
  • CARYA ILLINOINENSIS POLLEN 12 [hp_X]/mL
  • PINUS NIGRA POLLEN 12 [hp_X]/mL
  • PINUS TAEDA POLLEN 12 [hp_X]/mL
  • PINUS SYLVESTRIS POLLEN 12 [hp_X]/mL
  • POPULUS ALBA POLLEN 12 [hp_X]/mL
  • LIQUIDAMBAR STYRACIFLUA POLLEN 12 [hp_X]/mL
  • PLATANUS OCCIDENTALIS POLLEN 12 [hp_X]/mL
  • AILANTHUS ALTISSIMA POLLEN 12 [hp_X]/mL
  • SALIX NIGRA WHOLE 12 [hp_X]/mL
  • SORGHUM X DRUMMONDII WHOLE 12 [hp_X]/mL
  • JUGLANS NIGRA POLLEN 12 [hp_X]/mL
  • TRIADICA SEBIFERA WHOLE 12 [hp_X]/mL
  • QUERCUS RUBRA BARK 12 [hp_X]/mL
  • QUERCUS MACROCARPA POLLEN 12 [hp_X]/mL
  • QUERCUS STELLATA POLLEN 12 [hp_X]/mL
  • POPULUS NIGRA POLLEN 12 [hp_X]/mL
  • TAMARIX GALLICA POLLEN 12 [hp_X]/mL
  • BETULA OCCIDENTALIS WHOLE 12 [hp_X]/mL
  • ULMUS CRASSIFOLIA WHOLE 12 [hp_X]/mL
  • BACCHARIS HALIMIFOLIA WHOLE 12 [hp_X]/mL
  • CARYA CORDIFORMIS WHOLE 12 [hp_X]/mL
  • CARPINUS CAROLINIANA WHOLE 12 [hp_X]/mL
  • OSTRYA VIRGINIANA WHOLE 12 [hp_X]/mL
  • JUNIPERUS DEPPEANA WHOLE 12 [hp_X]/mL
  • LIGUSTRUM LUCIDUM WHOLE 12 [hp_X]/mL
  • MORUS ALBA WHOLE 12 [hp_X]/mL
  • QUERCUS ALBA WHOLE 12 [hp_X]/mL
  • FAGUS GRANDIFOLIA POLLEN 12 [hp_X]/mL
  • CARYA GLABRA POLLEN 12 [hp_X]/mL
  • CARYA OVATA POLLEN 12 [hp_X]/mL
  • CARYA LACINIOSA POLLEN 12 [hp_X]/mL
  • MELALEUCA QUINQUENERVIA POLLEN 12 [hp_X]/mL
  • QUERCUS NIGRA POLLEN 12 [hp_X]/mL
  • PINUS STROBUS POLLEN 12 [hp_X]/mL
  • POPULUS FREMONTII POLLEN 12 [hp_X]/mL
  • PINUS PONDEROSA POLLEN 12 [hp_X]/mL
  • QUERCUS GAMBELII POLLEN 12 [hp_X]/mL
  • JUNIPERUS OSTEOSPERMA POLLEN 12 [hp_X]/mL
  • JUNIPERUS SCOPULORUM POLLEN 12 [hp_X]/mL
  • ARTEMISIA VULGARIS WHOLE 30 [hp_X]/mL
  • GUTIERREZIA SAROTHRAE WHOLE 30 [hp_X]/mL
  • ARTEMISIA LUDOVICIANA WHOLE 30 [hp_X]/mL
  • AMBROSIA ACANTHICARPA POLLEN 30 [hp_X]/mL
  • AMBROSIA ARTEMISIIFOLIA POLLEN 30 [hp_X]/mL
  • SALSOLA KALI WHOLE 30 [hp_X]/mL
  • AMARANTHUS TUBERCULATUS POLLEN 30 [hp_X]/mL
  • ATRIPLEX CANESCENS POLLEN 30 [hp_X]/mL
  • ARTEMISIA ANNUA POLLEN 30 [hp_X]/mL
  • AMARANTHUS PALMERI POLLEN 30 [hp_X]/mL
  • AMBROSIA TRIFIDA POLLEN 30 [hp_X]/mL
  • AMBROSIA CONFERTIFLORA POLLEN 30 [hp_X]/mL
  • AMBROSIA BIDENTATA POLLEN 30 [hp_X]/mL
  • AMBROSIA PSILOSTACHYA POLLEN 30 [hp_X]/mL
  • QUERCUS VELUTINA WHOLE 30 [hp_X]/mL
  • BASSIA SCOPARIA POLLEN 30 [hp_X]/mL
  • AMARANTHUS HYBRIDUS POLLEN 30 [hp_X]/mL
  • XANTHIUM STRUMARIUM POLLEN 30 [hp_X]/mL
  • RUMEX ACETOSELLA POLLEN 30 [hp_X]/mL
  • RUMEX CRISPUS POLLEN 30 [hp_X]/mL
  • SOLIDAGO CANADENSIS WHOLE 30 [hp_X]/mL
  • CHENOPODIUM ALBUM POLLEN 30 [hp_X]/mL
  • CYCLACHAENA XANTHIFOLIA POLLEN 30 [hp_X]/mL
  • IVA ANGUSTIFOLIA POLLEN 30 [hp_X]/mL
  • URTICA DIOICA POLLEN 30 [hp_X]/mL
  • AMARANTHUS SPINOSUS POLLEN 30 [hp_X]/mL
  • AMARANTHUS RETROFLEXUS POLLEN 30 [hp_X]/mL
  • PLANTAGO LANCEOLATA POLLEN 30 [hp_X]/mL
  • ALLENROLFEA OCCIDENTALIS POLLEN 30 [hp_X]/mL
  • IVA ANNUA POLLEN 30 [hp_X]/mL
  • AMBROSIA DUMOSA POLLEN 30 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • STEVIA LEAF (UNII: 6TC6NN0876)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Gm Pharmaceuticals, Inc
Labeler Code: 58809
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-10-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Texaclear Natural Allergy Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Antigens 6X,12X,30X: Zones 2, 5, & 6 Grasses, Zones 2, 5, & 6 Trees, Zones 2, 5, & 6 Weeds; Herbal Drainage Remedies: Baptisia tinctoria HPUS, Echinacea 3X HPUS, Hydrastis canadensis HPUS, Myrrha HPUS, Nasturtium aquaticum HPUS, Phytolacca decandra HPUS, Trigonella foenum-graecum

Purpose:

Relief from sneezing, runny nose, itchy eyes and sinus congestion.

Uses:

This product is a homeopathic dilution formulated to support the body's immunity for the temporary relief of allergies.

Warnings

  • Use only as directed.

Stop Use And Ask A Doctor If

  • Symptoms worsen or do not improve after 5 days

If Pregnant Or Breast-Feeding,

Consult a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Shake well before useadults (12 and older) 10-15 drops under the tongue three times daily. children (under 12) 6 drops under the tongue three times daily or as directed by a health care professional. Consult a physician for use in children under 12 years of age.

Other Information:

Do no use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Inactive Ingredients:

Ethanol, purified water, stevia

* Please review the disclaimer below.

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