PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Important Safety Information for
PROVENTIL HFA Inhalation Aerosol

  • Do not use PROVENTIL HFA if you are allergic to albuterol sulfate or any of the ingredients of PROVENTIL HFA. Ask your doctor if you have questions.
  • If you find that your symptoms become significantly worse when you use PROVENTIL HFA Inhalation Aerosol, contact your doctor immediately because this reaction can be life threatening.

PROVENTIL HFA Inhaler should always be primed and used in an upright position and stored between 15° and 25° (59° and 77°F).

PROVENTIL HFA needs to be primed prior to first use and if not used for more than 14 days.

Important Safety Information for PROVENTIL® HFA (albuterol sulfate) Inhalation Aerosol (continued)

  • PROVENTIL HFA Inhalation Aerosol should not be used more frequently than recommended. Do not increase the number of puffs or frequency of doses of PROVENTIL HFA Inhalation Aerosol without consulting your physician. If you find that treatment with PROVENTIL HFA Inhalation Aerosol becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, medical attention should be sought immediately.
  • Tell your doctor if you have a heart, blood, or seizure disorder; high blood pressure; diabetes; or an overactive thyroid.
  • Some medicines can interfere with how well asthma medications work. Tell your doctor about all medicines you are taking, especially heart medicines and drugs that treat depression.
  • While you are taking PROVENTIL HFA Inhalation Aerosol, other inhaled drugs and asthma medications should be taken only as directed by your physician.
  • If you are pregnant or nursing, contact your physician about the use of PROVENTIL HFA Inhalation Aerosol.
  • The most common side effects with the use of PROVENTIL HFA Inhalation Aerosol include infection of the ears, nose, and throat; runny nose; nausea; tremor; nervousness; rapid heart beat; vomiting; chest pain; and palpitation.

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.

Please read the Patient's Instructions for Use and discuss it with your doctor. The physician Prescribing Information also is available.

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