Tusnel Liquid
FDA Label NDC 54859-507

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division, Inc. for the product Tusnel (NDC 54859-507). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

In each 5 mL

Guaifenesin - 100 mg

Otc - Purpose

Purpose

Expectorant

Indications & Usage

Uses

  • temporarily relieves cough due to minor thraot and bronchial irritations as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Warnings

Do not use if you are now taking a prescritpion monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's diesease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescirption drug contains an MAOI, aska doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    • Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeing, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions: Do not exceed more than 6 doses in any 24-hour period.

 Age Dose
 Adults and children over 12 years and over 2 teaspoonfuls (10 mL) every 4 hours
 Children under 12 years Ask a doctor

Inactive Ingredient

Inactive ingredients anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate digydrate, and a sucralose.

Otc - Questions

Questions or comments? 1-8660595-5598

Package Label.Principal Display Panel

Tusnelex (Tusneex)

Tusnelex (Tusneex)

* Please review the disclaimer below.