FDA Label for Tusnel Cough Suppressant Expectorant

View Indications, Usage & Precautions

Tusnel Cough Suppressant Expectorant Product Label

The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceutical International Division, Inc.. 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



In each 5 mL

Dextromethorphan - 10 mg

Guaifenesin - 100 mg


Otc - Purpose



Purpose

Cough Suppressant

Expectorant


Indications & Usage



Uses

  • temporarily relieves cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive

Warnings



Warnings

Do not use if you are now taking a prescritpion monamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's diesease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescirption drug contains an MAOI, aska doctor or pharmacist before taking this product.

Do not use if you have ever had an allergic reaction to any of the ingredients in this product.

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or head that lasts. These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



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


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 (1-800-222-1222)right away.


Dosage & Administration



Directions: 

  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose
  •  Age Dose
     Adults and children over 12 years and over 2 teaspoonfuls (10 mL)
     Children under 12 years do not use


Inactive Ingredient



Inactive ingredients cherry flavor, citric acid, FD&C #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.


Otc - Questions



Questions or comments? 1-866-595-5598


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