Texaclear Kids Allergy Liquid
FDA Label NDC 58809-925

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 Kids Allergy (NDC 58809-925). 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, ask a doctor before use if you have, ask a doctor before use if you are, when using this product, if pregnant or breast-feeding,, keep out of reach of children., 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 12.5 mg
Pyrilamine Maleate 25 mg

Purpose

Cough Suppressant
Antihistamine

Uses

temporarily relieves these symptoms due to the common cold, hay fever, or other upper respiratory allergies:

  • itchy nose or throat
  • sneezing
  • itchy, watery eyes      
  • runny nose
  • cough 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 directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

    • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • symptoms 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 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 4 doses per 24 hours

▪ mL= milliliter

▪ use enclosed dose cup and keep with product

adults and children 12 years of age and over:60 mL (2 dose cups) every 6 to 8 hours
children 6 to under 12 years of age:30 mL (1 dose cup) every 6 to 8 hours
children 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

Questions Or Comments?

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

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

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TexaClear® Kids Allergy + Cough
NDC 58809-925-08
8 fl. oz. (237 mL)

Chlophedianol HCl – Cough Suppressant
Pyrilamine Maleate – Antihistamine

Tamper evident: do not use if foil seal under cap is broken on missing

  • Gluten Free
  • Dye Free
  • Sugar Free
  • Alcohol Free
  • Acetaminophen Free

    • Ages 6+
    Dose every 6 to 8 hours

    • Sneezing
    • Runny Nose
    • Watery Eyes
    • Itchy Nose & Throat
    • Cough

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

      Texaclear® Kids Allergy + Coughndc 58809-925-088 Fl. Oz. (237 mL)chlophedianol HCl – Cough Suppressant Pyrilamine Maleate – Antihistaminetamper Evident: Do Not Use If Foil Seal Under Cap Is Broken On Missing• Gluten Free• Dye Free• Sugar Free• Alcohol Free• Acetaminophen Freeages 6+dose Every 6 To 8 Hours• Sneezing• Runny Nose• Watery Eyes• Itchy Nose & Throat• Coughdistributed By: Gm Pharmaceuticals, Inc. Arlington, Tx 76015 (Texaclear Kids Allergy 01)

      Texaclear® Kids Allergy + Coughndc 58809-925-088 Fl. Oz. (237 mL)chlophedianol HCl – Cough Suppressant Pyrilamine Maleate – Antihistaminetamper Evident: Do Not Use If Foil Seal Under Cap Is Broken On Missing• Gluten Free• Dye Free• Sugar Free• Alcohol Free• Acetaminophen Freeages 6+dose Every 6 To 8 Hours• Sneezing• Runny Nose• Watery Eyes• Itchy Nose & Throat• Coughdistributed By: Gm Pharmaceuticals, Inc. Arlington, Tx 76015 (Texaclear Kids Allergy 01)

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