Tusnel
FDA Label NDC 54859-520

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 54859-520). 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, otc - pregnancy or breast feeding, dosage & administration, indications & usage, 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

Codeine Phosphate ................................................. 10 mg .......... Cough Suppressant

Guaifenesin .......................................................... 100 mg .................. Expectorant

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



Otc - Purpose

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves: nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis, cough due to minor bronchial irritation as may occur with the common cold
  • temporarily restores freer breathing through the nose
  • calms the cough control center and relieves coughing

Warnings

WarningsDo not use if you are now 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 prescription drug contains anMAOI, ask a doctor or pharmacist before taking this product.When using this productdo nol exceed recommended dosage• may cause or aggravate constipation

Otc - Do Not Use


Ask a doctor before use if you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus) 
  • a breathing problem or persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. chronic pulmonary disease or shortness of breath, or who are taking other drugs
    • Stop use and ask a doctor if
    • you get nervous, dizzy or sleepless. symptoms do not get better within 7 days or are accompanied by fever. cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistant headache. 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 helpor 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: Follow dosage chart
Dosage may be repeated every 6 hours. Not to exceed 4 doses in 24-hours. Giving a higher dose
than recommended by a doctor could result in serious side effects for your child. A special measuring
device should be used to give an accurate dose of this product to children under 6 years of age.

Age
WeightDose
children 12 years of age and over
95 lbs and up
 Take 2 teaspoonfuls (10 mL)
 every 6 hours
Children 6 to under 12 years of age
45 lbs to under 95 lbs
 Take 1 teaspoonful (5mL)
 every 6 hours
Children under 6 years of age
under 45 lbs
 ask a doctor

Indications & Usage


Other information
  • store at controlled room temperature 20°- 25°C (68°- 77°F)
  • Each teaspoonful (5 ml) contains: sodium 2mg
    • Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.

Inactive Ingredient

Inactive ingredients aspartame, citric acid, glycerine, methylparaben,natural and artificial flavors, potassium citrate, potassium sorbate,propylene glycol, propylparaben, purified water.

Otc - Questions

Questions or Comments? 1-866-595-5598

* Please review the disclaimer below.