Texaclear Tablet
FDA Label NDC 58809-186

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 (NDC 58809-186). 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 (per tablet), 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 (Per Tablet)

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:

  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat
  • sneezing
  • cough due to minor throat and bronchial irritation

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:

  • cough persists for more than 1 week, 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 profession 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 take more than directed
  • do not take more than 4 tablets in any 24-hour period.
  • adults and children 12 years of age and over: Take 1 tablet every 6-8 hours
  • children under the age of 12:  do not use

Other Information

  • avoid excess heat and humidity
  • Store at room temperature 20-25 C(68-77 F)

Inactive Ingredients

Croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch  

Questions Or Comments?

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

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