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.

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.


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: 12-31-2023 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* 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.