FDA Label for Tusnel

View Indications, Usage & Precautions

Tusnel Product Label

The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceutical International Division. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients(in each 5 ml tsp.)                                  Purpose

Dextromethorphan HBr........15mg..................................................Cough Suppressant

Guaifenesin........................200mg................................................Expectorant

Pseudoephedrine HCl..........30mg..................................................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.

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement 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 you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

    Stop use and ask a doctor if

    • 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 - 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.


Otc - Pregnancy Or Breast Feeding




If pregnant or breast-feeding, ask a health professional before use.


Dosage & Administration




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

AgeDose
Adults and children
12 years of age and over
 Take 2 teaspoonfuls (10 mL)
 every 6 hours


Indications & Usage



Uses:

  • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold
  • helps control reflex that causes coughing
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies (allergic rhinitis).

Inactive Ingredient



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


Otc - Questions



Questions or Comments? 1-866-595-5598


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