Tusnel Pediatric Liquid
FDA Label NDC 54859-604

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 Pediatric (NDC 54859-604). 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

Dextromethorphan HBr - 5 mg

Guaifenesin - 75 mg

Phenylephrine HCl - 2.5 mg

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Indications & Usage

Uses

  • temporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold

Warnings

Warnings

Do not use if your child is taking a 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargment 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 your child is

    • taking sedatives, tranquilizers or drugs for depression or MAOI drugs.
      • Stop use and ask a doctor if your child gets
      • 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 - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a doctor before use

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.

Dosage & Administration

Directions: Do not exceed 6 doses in 24 hour

 Age Dose
Children 6 to under 12 years of age Take 2 teaspoonful (10 mL) every 4 hours
Children 2 to under 6 years of age  Take 1 teaspoonful (5 mL) every 4 hours
Children under 2 years of age Ask a doctor

Inactive Ingredient

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

Otc - Questions

Questions or Comments? 1-866-595-5598

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