Tusnel Pediatric
FDA Label NDC 54859-602

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 Pediatric (NDC 54859-602). 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 1 mL (dropperful)                    Purpose

Guaifenesin........................25mg................................................Expectorant

Pseudoephedrine HCl..........7.5mg..............................................Nasal Decongestant



Otc - Purpose

Uses
  • temporarily relieves these symptoms due to the common cold and thin bronchial secretions to make coughs more productive

Warnings

WarningsDo not use in child who is taking a prescription monoamine oxidaseinhibitor (MAOI) (certain drugs for depression, psychiatric, or emotionalconditions, or Parkinson’s disease), or for 2 weeks after stopping theMAOI drug. If you do not know if your child's prescription drug contains anMAOI, ask a doctor or pharmacist before giving 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.

Age
WeightDose
Children 2 to under
6 years of age		24 -47 lbs
 Take 2 mL (two dropperfuls)
 every 4 to 6 hours
Children under 2 years of age
Under 24 lbs
 ask a doctor

Indications & Usage


Other information
  • store at controlled room temperature 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature]
  • Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering
  • Oral dosing device enclosed

Inactive Ingredient

Inactive ingredients citric acid, D and C Red Number 33,FD and C Blue #1, flavor, glycerin, propylene glycol, sodium benzoate, sodium saccharin, water.

Otc - Questions

Questions or Comments? 1-866-595-5598

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