Texaclear Fast Acting Allergy Relief Liquid
FDA Label NDC 58809-360

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gm Pharmaceuticals, Inc for the product Texaclear Fast Acting Allergy Relief (NDC 58809-360). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 30 ml), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 30 Ml)

Chlophedianol HCl 25 mg 

Pyrilamine Maleate 50 mg

Purpose

Cough suppressant

Antihistamine

Uses

  • temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

Do not exceed recommended dosage.

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

When Using This Product

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days, tends to recur, or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • new 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.

Directions

  • do not exceed recommended dosage.
  • do not take more than 4 doses in any 24-hour period
  • dose as follows or as directed by a doctor
  • use enclosed dosing cup
  • do not use dosing cup with other products
  • mL = milliliters
    • adult and children 12 years and over30mL every 6-8 hours
    children under 12do not use

Other Information

  • each 30 mL contains: Sodium 17 mg.
  • tamper evident: Do not use if foil seal under cap is broken or missing.
  • Read all product information before using
  • store at 68° to 86°F (20° to 30°C).
  • avoid excessive heat and humidity

Inactive Ingredients

citric acid anhydrous, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol

Questions Or Comments?

Call 1-888-535-0305 9 a.m- 5p.m CST

Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76015

Principal Display Panel

NDC 58809-360-08
TEXACLEAR
Fast Acting
ALLERGY
RELIEF
8 fl oz (237 mL)

Principal Display Panelndc 58809-360-08texaclearfast Actingallergyrelief8 Fl Oz (237 mL) (Texaclear Fast Acting Allergy Relief 01)

Principal Display Panelndc 58809-360-08texaclearfast Actingallergyrelief8 Fl Oz (237 mL) (Texaclear Fast Acting Allergy Relief 01)

* Please review the disclaimer below.