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IMPORTANT INFORMATION ABOUT PULMICORT RESPULES

Important Safety Information

PULMICORT RESPULES is not a bronchodilator and should NOT be used to treat an acute asthma attack. If your child is switching to PULMICORT RESPULES from an oral corticosteroid, follow the doctor's instructions to avoid serious health risks when your child stops using oral corticosteroids.

Only use PULMICORT RESPULES with a jet nebulizer machine that is connected to an air compressor. Do not use an ultrasonic nebulizer.

Thrush infection of the mouth and throat may occur with PULMICORT RESPULES.

Avoid exposure of your child to infections such as chicken pox and measles. Tell your doctor immediately if your child is exposed.

Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult height is unknown.

PULMICORT RESPULES should not be used if your child is allergic to budesonide or any of the ingredients.

Be sure to tell the healthcare provider about all your child's health conditions and all medicines he or she may be taking.

As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with PULMICORT RESPULES, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with PULMICORT RESPULES should be stopped and your physician consulted.

The most common side effects include respiratory infection, runny nose, coughing, ear infection, viral infection, thrush in the mouth and throat, inflammation of the stomach including vomiting, diarrhea, abdominal pain and loss of appetite, nose bleed, pink eye, and rash.

Approved Use

PULMICORT RESPULES^® (budesonide inhalation suspension) is a maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.

Please click here for full Prescribing Information for PULMICORT RESPULES.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.