Tusnel Liquid
FDA Label NDC 54859-544

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 54859-544). 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 - do not use, otc - keep out of reach of children, 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........5mg..................................................Cough Suppressant

Guaifenesin........................50mg................................................Expectorant

Pseudoephedrine HCl..........15mg..................................................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.

Otc - Do Not Use


Ask a doctor before use if your child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • a cough that occurs with too much phlegm (mucus)
  • a persistent or chronic cough such as occurs with asthma


    • When using this product

    • do not exceed recommended dosage

      • Stop use and ask a doctor if

      • nervousness, dizziness or sleeplessness occurs
      • symptoms do not get better within 7 days or accompanied by fever
      • cough last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could be a sign 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.

Dosage & Administration

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

AgeWeightDose
Children 6 to under
12 years of age		45 lbs to under
95 lbs		 Take 2 teaspoonfuls (10 mL)
 every 4 to 6 hours
Children 2 to under
6 years of age		25 lbs to under
45 lbs		 Take 1 teaspoonful (5mL)
 every 4 to 6 hours
Children under 2 years of ageUnder 25 lbs ask a doctor

Indications & Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves these symptoms occurring with a cold: nasal congestions, cough due to minor throat and bronchial irritation.

Inactive Ingredient


Inactive ingredients astificial and natural flavor, citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralos

Otc - Questions

Questions or Comments? 1-866-595-5598

Package Label.Principal Display Panel

Tusnelpediatriclabel (Tusnelpediatricliq)

Tusnelpediatriclabel (Tusnelpediatricliq)

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