Primatene® MIST Drug Facts

Active ingredient (in each spray)
Purpose

Epinephrine 0.125 mg......Bronchodilator

Uses

For temporary relief of mild symptoms of intermittent asthma

  • wheezing
  • tightness of chest
  • shortness of breath

Warnings

For oral inhalation only

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 your asthma is getting worse.

Do not use

  • unless a doctor said you have asthma
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product

Ask a doctor before use if you have

  • ever been hospitalized for asthma
  • heart disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • thyroid disease
  • seizures
  • narrow angle glaucoma

Ask a doctor or pharmacist before use if you are

  • taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions
  • taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as allergy, cough-cold, or pain)

When using this product

  • your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death
  • your risk of heart attack or stroke increases if you:
    • have a history of high blood pressure or heart disease
    • take this product more frequently or take more than the recommended dose
  • avoid foods or beverages that contain caffeine
  • avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect
  • avoid spraying in eyes
  • contents under pressure. Do not puncture or incinerate.
  • do not store near open flame or heat above 120°F (49°C). May cause bursting

Stop use and ask a doctor if

  • your asthma is getting worse (see asthma alert)
  • you have difficulty sleeping
  • you have a rapid heart beat
  • you have tremors, nervousness, or seizure

If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • read the Consumer Information Insert for detailed directions on how to use this product
  • do not use more than directed
  • for adults and children 12 years of age and over
  • children under 12 years of age: do not use; it is not known if the drug works or is safe in children under 12

Before first use (new inhaler)

activate new inhaler by shaking then spraying into air 4 separate times

each time you dose

  • remove red cap (if attached)
  • shake then spray into the air 1 time
  • exhale completely, place inhaler in mouth
  • inhale deeply while pressing down on top of inhaler, then continue the deep breath
  • hold breath as long as possible, exhale
  • wait 1 minute. If symptoms not relieved, take a second inhalation by repeating steps above

after use

  • wait at least 4 hours between doses
  • do not use more than 8 inhalations in 24 hours
  • wash inhaler after each day of use. Run water through the mouthpiece for 30 seconds

Other information

  • store at room temperature, between 15-25°C (59-77°F)
  • contains no sulfites
  • keep this label and enclosed materials. They contain important additional information

Inactive ingredients
dehydrated alcohol (1%), hydrofluoroalkane (HFA 134a), polysorbate 80, thymol

Questions or comments?
Call 1-8-Primatene or 1-877-462-8363
Monday - Friday, 7 am - 5 pm PT

Manufactured by:
Armstrong Pharmaceuticals, Inc.
Canton, MA 02021
© 2018 Made in USA