NDC 58809-207 Texaclear Homeopathic Allergy Relief Kids Cedar Fever

Over 100 Extracts

NDC Product Code 58809-207

NDC CODE: 58809-207

Proprietary Name: Texaclear Homeopathic Allergy Relief Kids Cedar Fever What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Over 100 Extracts What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 58809 - Gm Pharmaceuticals, Inc
    • 58809-207 - Texaclear Homeopathic Allergy Relief

NDC 58809-207-30

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Texaclear Homeopathic Allergy Relief Kids Cedar Fever with NDC 58809-207 is a a human over the counter drug product labeled by Gm Pharmaceuticals, Inc. The generic name of Texaclear Homeopathic Allergy Relief Kids Cedar Fever is over 100 extracts. 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 Homeopathic Allergy Relief Kids Cedar Fever 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.

  • THUJA PLICATA LEAF 30 [hp_X]/mL
  • BACCHARIS HALIMIFOLIA WHOLE 30 [hp_X]/mL
  • LOLIUM PERENNE POLLEN 30 [hp_X]/mL
  • BETULA LENTA POLLEN 30 [hp_X]/mL
  • FRAXINUS AMERICANA POLLEN 30 [hp_X]/mL
  • BAPTISIA TINCTORIA ROOT 6 [hp_X]/mL
  • HYDRASTIS CANADENSIS WHOLE 6 [hp_X]/mL
  • MYRRH 6 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 6 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 6 [hp_X]/mL
  • FESTUCA PRATENSIS POLLEN 30 [hp_X]/mL
  • SORGHUM HALEPENSE POLLEN 30 [hp_X]/mL
  • DACTYLIS GLOMERATA POLLEN 30 [hp_X]/mL
  • ELYMUS REPENS POLLEN 30 [hp_X]/mL
  • PHLEUM PRATENSE POLLEN 30 [hp_X]/mL
  • TRITICUM AESTIVUM POLLEN 30 [hp_X]/mL
  • PHALARIS ARUNDINACEA POLLEN 30 [hp_X]/mL
  • ZEA MAYS POLLEN 30 [hp_X]/mL
  • SECALE CEREALE POLLEN 30 [hp_X]/mL
  • LOLIUM MULTIFLORUM POLLEN 30 [hp_X]/mL
  • ARTEMISIA TRIDENTATA POLLEN 30 [hp_X]/mL
  • ACACIA POLLEN 30 [hp_X]/mL
  • FRAXINUS VELUTINA POLLEN 30 [hp_X]/mL
  • FRAXINUS PENNSYLVANICA POLLEN 30 [hp_X]/mL
  • JUNIPERUS VIRGINIANA POLLEN 30 [hp_X]/mL
  • POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN 30 [hp_X]/mL
  • CUPRESSUS ARIZONICA POLLEN 30 [hp_X]/mL
  • TAXODIUM DISTICHUM 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
  • BROMUS INERMIS POLLEN 30 [hp_X]/mL
  • DISTICHLIS SPICATA POLLEN 30 [hp_X]/mL
  • ACER SACCHARUM POLLEN 30 [hp_X]/mL
  • BROUSSONETIA PAPYRIFERA POLLEN 30 [hp_X]/mL
  • MORUS RUBRA POLLEN 30 [hp_X]/mL
  • CARYA ILLINOINENSIS POLLEN 30 [hp_X]/mL
  • PINUS TAEDA POLLEN 30 [hp_X]/mL
  • POPULUS ALBA POLLEN 30 [hp_X]/mL
  • LIQUIDAMBAR STYRACIFLUA POLLEN 30 [hp_X]/mL
  • PLATANUS OCCIDENTALIS POLLEN 30 [hp_X]/mL
  • JUGLANS NIGRA POLLEN 30 [hp_X]/mL
  • TRIADICA SEBIFERA WHOLE 30 [hp_X]/mL
  • QUERCUS RUBRA BARK 30 [hp_X]/mL
  • QUERCUS MACROCARPA POLLEN 30 [hp_X]/mL
  • QUERCUS STELLATA POLLEN 30 [hp_X]/mL
  • POPULUS NIGRA POLLEN 30 [hp_X]/mL
  • BETULA OCCIDENTALIS WHOLE 30 [hp_X]/mL
  • CARYA CORDIFORMIS WHOLE 30 [hp_X]/mL
  • JUNIPERUS DEPPEANA WHOLE 30 [hp_X]/mL
  • LIGUSTRUM LUCIDUM WHOLE 30 [hp_X]/mL
  • MORUS ALBA WHOLE 30 [hp_X]/mL
  • QUERCUS ALBA WHOLE 30 [hp_X]/mL
  • FAGUS GRANDIFOLIA POLLEN 30 [hp_X]/mL
  • CARYA GLABRA POLLEN 30 [hp_X]/mL
  • CARYA OVATA POLLEN 30 [hp_X]/mL
  • CARYA LACINIOSA POLLEN 30 [hp_X]/mL
  • MELALEUCA QUINQUENERVIA POLLEN 30 [hp_X]/mL
  • THUJA OCCIDENTALIS LEAF 30 [hp_X]/mL
  • QUERCUS NIGRA POLLEN 30 [hp_X]/mL
  • PINUS STROBUS POLLEN 30 [hp_X]/mL
  • POPULUS FREMONTII POLLEN 30 [hp_X]/mL
  • PINUS PONDEROSA POLLEN 30 [hp_X]/mL
  • QUERCUS GAMBELII POLLEN 30 [hp_X]/mL
  • JUNIPERUS OSTEOSPERMA POLLEN 30 [hp_X]/mL
  • JUNIPERUS SCOPULORUM POLLEN 30 [hp_X]/mL
  • ARTEMISIA VULGARIS WHOLE 30 [hp_X]/mL
  • GUTIERREZIA SAROTHRAE WHOLE 30 [hp_X]/mL
  • AMBROSIA ACANTHICARPA 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
  • AGROSTIS GIGANTEA POLLEN 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
  • 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
  • AMBROSIA DUMOSA 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
  • PASCOPYRUM SMITHII POLLEN 30 [hp_X]/mL
  • ALNUS RHOMBIFOLIA POLLEN 30 [hp_X]/mL
  • JUNIPER BERRY 30 [hp_X]/mL
  • IVA ANNUA 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.

  • XYLITOL (UNII: VCQ006KQ1E)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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: 08-21-2020 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: 12-31-2021 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 Homeopathic Allergy Relief Kids Cedar Fever Product Label Images

Texaclear Homeopathic Allergy Relief Kids Cedar Fever 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

Other

TexaClear Kids Homeopathic Allergy ReliefActive 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 5XTexaClear Kids Homeopathic Allergy Relief
Drug Facts

Active Ingredient

Antigens 30X: **Zones 2,5,& 6 Grasses, **Zones 2,5,& 6 Trees, **Zones 2,5,& 6 Weeds;Herbal Drainage Remedies: Baptisia tinctoria 6X HPUS, Echinacea 6X HPUS, Hydrastis canadensis 6X HPUS, Myrrha 6X HPUS, Phytolacca decandra 6X HPUS

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. 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.

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.

Other Information:

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

Inactive Ingredients:

Glycerin, purified water, stevia, xylitol

Questions?

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

* Please review the disclaimer below.