About Primatene® MIST
For Temporary Relief of Mild Symptoms of Intermittent Asthma

Primatene® MIST is back and available over the counter—helping you breathe easier again with the same active ingredient you’ve trusted for temporary relief of mild symptoms of intermittent asthma plus some updated features.

Only FDA-Approved, Over-the-Counter Asthma Medicine Inhaler

For temporary relief of mild symptoms of intermittent asthma:

  • Wheezing
  • Tightness of chest
  • Shortness of breath

Asthma alert: Because asthma may be life threatening, see a doctor if you

  • are not better in 20 minutes
  • get worse
  • need more than 8 inhalations in 24 hours
  • have more than 2 asthma attacks in a week

These may be signs that your asthma is getting worse.

DOSING:

Shake then Spray into the Air

  1. Remove red cap.
  2. Shake then Spray into the air 1 time to mix the medicine.
  3. Inhale.
  4. Exhale completely.
  5. Place mouthpiece in your mouth with your lips closed around the opening.
  6. Inhale deeply while pressing down on the center of the spray indicator (top of container). Continue the deep breath.
  7. Hold your breath for as long as possible.
  8. Release finger and remove inhaler from mouth, then exhale slowly.

Wait at least 1 minute

  1. If symptoms are not relieved after at least 1 minute, take a second inhalation by repeating steps 2 to 7 above.

Replace red cap.

MAXIMUM DAILY DOSE

The maximum daily dose of Primatene® MIST is 8 inhalations in 24 hours. You should see your doctor if you have more than 2 asthma attacks in a week.

AGE 12 AND OLDER

Children under 12 years of age should not use Primatene® MIST. It is not known if the drug works or is safe in children under age 12. Adult supervision is recommended for younger teenagers.

What’s New?

The original formulation of the epinephrine inhaler was propelled by chlorofluorocarbons (CFCs). The original formulation was phased out in 2011 because the inhaler used CFCs to move the medicine out of the inhaler so patients could breathe the medicine into their lungs. The United States signed an international agreement, called the Montreal Protocol on Substances that Deplete the Ozone Layer, along with many other countries. In order to comply with the obligations made under the Protocol, participating countries agreed to phase out substances that deplete the ozone layer, including CFCs.

HERE’S WHAT’S NEW

The new inhaler is a CFC-free metered dose inhaler (MDI) that uses epinephrine as its active ingredient, the same active ingredient used in the previous inhaler. The new Primatene® MIST propelled by hydrofluoroalkane (HFA 134a) works differently from the old inhaler containing CFCs. Be sure to read the Consumer Information Insert for detailed directions on how to correctly use your new metered dose inhaler.

CHANGES TO THE ASTHMA MEDICINE CONTAINER:

The new medication container is a pressurized metal canister similar to canisters used in other metered dose inhalers available, instead of the glass container used in the previous inhaler propelled by chlorofluorocarbons (CFCs).

ADDITION OF A SPRAY INDICATOR:

The new Primatene® MIST has a built-in spray indicator that shows how many sprays of asthma medicine you have left in the container. A full container has 160 sprays. After every 20 sprays, the spray indicator number changes.

Updated instructions for using and washing the inhaler

image of page for checklist

Primatene® MIST Drug Facts

See complete information about what this product contains, what symptoms of asthma it is used to treat, warnings, safety information, and more.