Approved Uses

ProAir® Digihaler (albuterol sulfate) Inhalation Powder is a prescription medicine used in people 4 years of age and older to:

  • treat or prevent bronchospasm in people who have reversible obstructive airway disease
  • prevent exercise-induced bronchospasm

ProAir Digihaler contains a built-in electronic module that detects, records and stores inhaler event information. ProAir Digihaler may be used with, and transmits information to, a mobile app. ProAir Digihaler does not need to be connected to the mobile app in order for you to take your medicine.

Important Safety Information

Do not use ProAir Digihaler (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, milk proteins, or any of the ingredients in ProAir Digihaler. Ask your healthcare provider if you have any questions or are not sure

Before using ProAir Digihaler, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems
  • have high blood pressure (hypertension)
  • have convulsions (seizures)
  • have thyroid problems
  • have diabetes
  • have low potassium levels in your blood
  • are pregnant or planning to become pregnant
  • are breastfeeding or planning to breastfeed

Tell your healthcare provider about all the medicines you take, especially:

  • other inhaled medicines or asthma medicines
  • beta blocker medicines
  • diuretics
  • digoxin
  • monoamine oxidase inhibitors
  • tricyclic antidepressants

Do not increase your dose or take extra doses of ProAir Digihaler without first talking to your healthcare provider

Get medical help right away if ProAir Digihaler no longer helps your symptoms, your symptoms get worse or you need to use your inhaler more often

While you are using ProAir Digihaler, do not use other inhaled rescue medicines and asthma medicines unless your healthcare provider tells you to do so

ProAir Digihaler may cause serious side effects, including:

  • worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens, stop using ProAir Digihaler and call your healthcare provider or get emergency help right away. This is more likely to happen with your first use of a new asthma inhalation medicine
  • heart problems, including faster heart rate and higher blood pressure
  • possible death in people with asthma who use too much ProAir Digihaler
  • allergic reactions. Call your healthcare provider right away if you have the following symptoms of an allergic reaction:
    • itchy skin
    • swelling beneath your skin or in your throat
    • rash
    • worsening trouble breathing
  • changes in laboratory blood values (sugar, potassium)

The most common side effects of ProAir Digihaler include:

  • back pain
  • body aches and pain
  • upset stomach
  • sinus headache
  • urinary tract infection
  • your heart feels like it is pounding or racing (palpitations)
  • chest pain
  • fast heart rate
  • shakiness
  • nervousness
  • headache
  • dizziness
  • sore throat
  • runny nose

These are not all of the possible side effects of ProAir Digihaler. For more information, ask your healthcare provider or pharmacist

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 see full Prescribing Information for ProAir® Digihaler.

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Teva could void the user’s authority to operate the equipment.