Label: PRIMATENE MIST- epinephrine inhalation aerosol

  • NDC Code(s): 17270-553-00
  • Packager: Armstrong Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 3, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each spray)

    Epinephrine 0.125 mg

  • Purpose

    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 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
    Bronchodilator
    For Oral
    Inhalation Only

    For TEMPORARY relief
    of MILD symptoms
    of INTERMITTENT asthma

    Suspension:
    Shake then Spray
    into the air before
    each inhalation.

    This item is

    electronically

    protected

    NEW FORMULATION:
    See Important Usage
    Information on Insert
    and on Side Panels

    160 Metered Sprays
    Net Weight: 11.7g

    carton

  • INGREDIENTS AND APPEARANCE
    PRIMATENE MIST 
    epinephrine inhalation aerosol
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17270-553
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE125 ug
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    NORFLURANE (UNII: DH9E53K1Y8)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17270-553-001 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
    NDANDA20592012/14/2018
    Labeler - Armstrong Pharmaceuticals, Inc. (809773794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Armstrong Pharmaceuticals, Inc.809773794manufacture(17270-553) , analysis(17270-553) , pack(17270-553)