NDC 58809-925 Texaclear Kids Allergy

Chlophedianol Hcl Pyrilamine Maleate

NDC Product Code 58809-925

NDC 58809-925-08

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Texaclear Kids Allergy with NDC 58809-925 is a a human over the counter drug product labeled by Gm Pharmaceuticals, Inc. The generic name of Texaclear Kids Allergy is chlophedianol hcl pyrilamine maleate. The product's dosage form is liquid and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1808189.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 Kids Allergy 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.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

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
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 06-15-2016 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 - 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 Kids Allergy 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 Ingredients (In Each 30 Ml)

Chlophedianol HCl 12.5 mg Pyrilamine Maleate 25 mg


Cough SuppressantAntihistamine


  • Temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:itchy nose or throat sneezingitchy, watery eyes
  • Runny nosecough due to minor throat and bronchial irritation

Ask A Doctor Before Use If You Have

▪ a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema▪ glaucoma▪ difficulty in urination due to enlargement of the prostate gland▪ cough that occurs with too much phlegm (mucus)▪ a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Before Use If You Are

▪ taking sedative or tranquilizers

When Using This Product

  • Do not use more than directedmarked drowsiness may occuravoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in childrenStop use and ask a doctor ifnervousness, dizziness, or sleeplessness occurssymptoms do not improve within 7 days, tend to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious conditionnew symptoms occur

If Pregnant Or Breast-Feeding,

Ask 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.


▪ do not exceed 4 doses per 24 hours▪ mL= milliliter▪ use enclosed dose cup and keep with productadults and children 12 years of age and over:60 mL (2 dose cups) every 6 to 8 hourschildren 6 to under 12 years of age:30 mL (1 dose cup) every 6 to 8 hourschildren under 6 years:do not use.

Other Information

▪ each 30 mL contains: Sodium 14 mg▪ read all product information before using▪ store at room temperature 68-86°F (20-30°C)

Inactive Ingredients

Citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

* Please review the disclaimer below.