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  5. Label Information: Tusnel EX

FDA Label for Tusnel EX

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. OTC - QUESTIONS
    10. HOW SUPPLIED

Tusnel EX Product Label

The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. 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

Guaifenesin - 100 mg


Otc - Purpose



Purpose

Expectorant


Indications & Usage



Uses

  • temporarily relieves cough due to minor thraot and bronchial irritations as may occur with a cold
  • helps loosen phlegm (mucus) and 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.

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 persistent headache. A persistent cough may be a sign 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 right away.


Dosage & Administration



Directions: Do not exceed more than 6 doses in any 24-hour period.

 Age Dose
 Adults and children over 12 years and over 2 teaspoonfuls (10 mL) every 4 hours
 Children under 12 years Ask a doctor


Inactive Ingredient



Inactive ingredients anhydrous citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate digydrate, and a sucralose.


Otc - Questions



Questions or comments? 1-8660595-5598


How Supplied



Product: 50090-6542

NDC: 50090-6542-0 118 mL in a BOTTLE


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