FDA Label for Tusnel Diabetic

View Indications, Usage & Precautions

Tusnel Diabetic Product Label

The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceuticals 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 USP........ 10 mg ................................. Cough Suppressant

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


Otc - Purpose



Purpose

Cough Suppressant

Expectorant


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 if 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 giving this product.


Otc - Do Not Use



Ask a doctor before use if you have

  • a 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 last more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. A persistent cough could b a sign of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children. In case of overdose, get medical help or contact a Poison 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 6 doses in any 24-hour period or as directed by a doctor.

 Age Dose
 Adults and children 12 years of age and over 2 teaspoonfuls (10 mL) every 4 hours
 Under 2 years of age Do not use


Indications & Usage



Uses
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive


Inactive Ingredient



Inactive Ingredients: anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate dihydrate and sucralose.


Otc - Questions



Questions or Comments? 1-866-595-5598

Distributed By: Llorens International Division, Miami FL 33165


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