Tusnel Pediatric Drops Solution/ Drops
FDA Label NDC 54859-605

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 Pharmaceuticals International Division for the product Tusnel Pediatric Drops (NDC 54859-605). 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 - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, 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 (1 mL)

Guaifenesin 25 mg

Phenylephrine HCl 1.25 mg

Otc - Purpose

Purpose

Expectorant

Nasal Decongestant

Indications & Usage

Uses

  • Temporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productive
  • Helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.

Warnings

Warnings

Do not use in child whos is 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 child's prescription drug contains an MAOI: ask your doctor or pharmacist before giving this product.

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
  • a persistent or chronic cough that occurs with asthma, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

    • When using this product

    • do not exceed the recommended dosage.

      • Stop use and ask doctor if

      • nervousness, dizziness or sleeplessness occurs
      • symptoms do not get better within 7 days or accompanied by fever
      • cough lasts 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 - Keep Out Of Reach Of Children

Keep out of reach of children. In case 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.

 Age Weight Dose
 Children 2 to under 6 years of age 24-47 lbs Take 2 mL every 4-6 hours
 Children under 2 years of age Under 24 lbs Ask a doctor

Inactive Ingredient

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

Otc - Questions

Questions or Comments? 1-866-595-5598

Package Label.Principal Display Panel

Tusnelped (Tusnelpeddrops)

Tusnelped (Tusnelpeddrops)

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