Label: PRIMATENE MIST- epinephrine inhalation aerosol

  • NDC Code(s): 17270-5530-0
  • Packager: Armstrong Pharmaceuticals, Inc.
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated June 5, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient (in each spray)

    Epinephrine 0.125 mg

  • Purpose


  • 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 that 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 a 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 for 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

    Mon.- Fri. 7 am - 5 pm PST

  • Primatene MIST® Carton

    Principal Display Panel Text:

    Primatene MIST®

    Epinephrine Inhalation Aerosol
    0.125 mg per spray
    For Oral
    Inhalation Only

    For TEMPORARY relief
    of MILD symptoms
    of INTERMITTENT asthma

    Shake then Spray
    into the air before
    each inhalation.

    This item is



    See Important Usage
    Information on Insert
    and on Side Panels

    160 Metered Sprays
    Net Weight: 11.7g


    epinephrine inhalation aerosol
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17270-5530
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    THYMOL (UNII: 3J50XA376E)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17270-5530-01 in 1 CARTON12/14/2018
    1160 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Armstrong Pharmaceuticals, Inc. (809773794)
    NameAddressID/FEIBusiness Operations
    Armstrong Pharmaceuticals, Inc.809773794manufacture(17270-5530) , analysis(17270-5530)