Tusnel Liquid
FDA Label NDC 54859-502

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 for the product Tusnel (NDC 54859-502). 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, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, 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

Active Ingredients(in each 5 ml tsp.)                                  Purpose

Dextromethorphan HBr........15mg..................................................Cough Suppressant

Guaifenesin........................200mg................................................Expectorant

Pseudoephedrine HCl..........30mg..................................................Nasal Decongestant



Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings


Warnings
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional
conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of prostate gland
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    • Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition

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.

Otc - Pregnancy Or Breast Feeding


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

Dosage & Administration


Directions Do not exceed more than 4 doses in any 24-hour period
or as directed by a doctor.

AgeDose
Adults and children
12 years of age and over		 Take 2 teaspoonfuls (10 mL)
 every 6 hours

Indications & Usage

Uses:

  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps control reflex that causes coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis).

Inactive Ingredient

Inactive ingredients: artificial grape flavor, citric acid, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate and sucralose.

Otc - Questions

Questions or Comments? 1-866-595-5598

Package Label.Principal Display Panel

Tusnelliquidlabel (Tusnelliquid)

Tusnelliquidlabel (Tusnelliquid)

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