Label: PRIMATENE MIST - epinephrine inhalant PRIMATENE MIST REFILL - epinephrine inhalant 

  • Label RSS
  • NDC Code(s): 17270-503-00, 17270-504-00
  • Packager: Armstrong Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/10

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

  • SPL UNCLASSIFIED SECTION

    Primatene® Mist (CFC) will not be available after December 31, 2011.
    Talk to your doctor and/or pharmacist about other asthma medicines.

    Drug Facts

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  • Active ingredient (in each inhalation)

    Epinephrine 0.22 mg

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  • Purpose

    Bronchodilator

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  • Uses

    • for temporary relief of occasional symptoms of mild asthma:
      • wheezing
      • tightness of chest
      • shortness of breath
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  • Warnings

    Asthma alert

    Because asthma can be life threatening, see a doctor if you

    • are not better in 20 minutes
    • get worse
    • need 12 inhalations in any day
    • use more than 9 inhalations a day for more than 3 days a week
    • have more than 2 asthma attacks in a week

    For inhalation only

    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
    • thyroid disease
    • seizures
    • narrow angle glaucoma
    • a psychiatric or emotional condition
    • trouble urinating due to an enlarged prostate gland

    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

    • Increased blood pressure or heart rate can occur, which could lead to more serious problems such as heart attack and stroke. Your risk may increase if you take more frequently or more than the recommeded dose.
    • nervousness, sleeplessness, rapid heart beat, tremor, and seizure may occur. If these symptoms persist or get worse, consult a doctor right away.
    • avoid caffeine-containing foods or beverages.
    • avoid dietary supplements containing ingredients reported or claimed to have stimulant effect.
    • do not puncture or throw into incinerator. Contents under pressure.
    • do not use or store near open flame or heat above 120°F (49°C). May cause bursting.

    Contains CFC 12, 114, substances which harm public health and environment by destroying ozone in the upper atmosphere.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • do not exceed dosage
    • supervise children using this product
    • adults and children 4 years and over: start with one inhalation, then wait at least 1minute. If not relieved, use once more. Do not use again for at least 3 hours.
    • children under 4 years of age: ask a doctor
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  • Other information

    • store at room temperature, between 20-25°C (68-77°F)
    • contains no sulfites
    • see insert for mouthpiece use and care instructions
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  • Inactive ingredients

    ascorbic acid, dehydrated alcohol (34%), dichlorodifluoromethane (CFC 12), dichlorotetrafluoroethane (CFC 114), hydrochloric acid, nitric acid, purified water

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  • Questions or comments?

    call 1-8 PRIMATENE or 1-877-462-8363

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  • DIRECTIONS FOR USE OF MOUTHPIECE

    The Primatene Mist mouthpiece, which is enclosed in the Primatene Mist 15 mL size (not the refill size), should be used for inhalation only with Primatene Mist.

    1. Take plastic cap off mouthpiece. (For refills, use mouthpiece from previous purchase.) Figure
    2. Take plastic mouthpiece off bottle. Figure
    3. Place short end of mouthpiece on bottle. Figure
    4. Turn bottle upside down. Place thumb on bottom of mouthpiece over circular button and forefinger on top of vial. Empty the lungs as completely as possible by exhaling. Figure
    5. Place mouthpiece in mouth with lips closed around opening. Inhale deeply while squeezing mouthpiece and bottle together. Release immediately and remove unit from mouth, then complete taking the deep breath, drawing medication into your lungs, holding breath as long as comfortable. Figure
    6. Exhale slowly keeping lips nearly closed. This helps distribute the medication in the lungs. Figure
    7. For storage, place long end of mouthpiece back on bottle and cover with plastic cap. Figure
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  • CARE OF THE MOUTHPIECE

    The Primatene Mist mouthpiece should be washed after each use with hot, soapy water, rinsed thoroughly, and dried with a clean, lint-free cloth.

    If the unit becomes clogged and fails to spray, please write and send the clogged unit to:
    Armstrong Pharmaceuticals, Inc., 423 La Grange Street, West Roxbury, MA 02132

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  • PRINCIPAL DISPLAY PANEL - 15 mL Carton

    Primatene®
    MIST

    Epinephrine Inhalation Aerosol Bronchodilator

    For the Temporary Relief of
    BRONCHIAL ASTHMA

    WITH MOUTHPIECE FOR ORAL INHALATION

    Primatene® Mist (CFC) will not be available after December 31, 2011.
    Talk to your doctor and/or pharmacist about other asthma medicines.

    1/2 FL OZ (15 mL)

    Principal Display Panel - 15 mL Carton
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  • PRINCIPAL DISPLAY PANEL - 15 mL Refill Carton

    Primatene®
    MIST

    Epinephrine Inhalation Aerosol Bronchodilator

    For the Temporary Relief of
    BRONCHIAL ASTHMA

    INHALER
    REFILL

    USE WITH
    PRIMATENE
    MOUTHPIECE

    Primatene® Mist (CFC) will not be available after December 31, 2011.
    Talk to your doctor and/or pharmacist about other asthma medicines.

    1/2 FL OZ (15 mL)

    Principal Display Panel - 15 mL Refill Carton
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  • INGREDIENTS AND APPEARANCE
    PRIMATENE MIST 
    epinephrine inhalant
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17270-503
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Epinephrine (Epinephrine) Epinephrine 0.22 mg
    Inactive Ingredients
    Ingredient Name Strength
    Ascorbic Acid  
    alcohol  
    dichlorodifluoromethane  
    dichlorotetrafluoroethane  
    hydrochloric acid  
    nitric acid  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17270-503-00 1 in 1 CARTON
    1 300 in 1 INHALER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA087907 05/23/1984
    PRIMATENE MIST REFILL 
    epinephrine inhalant
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17270-504
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Epinephrine (Epinephrine) Epinephrine 0.22 mg
    Inactive Ingredients
    Ingredient Name Strength
    Ascorbic Acid  
    alcohol  
    dichlorodifluoromethane  
    dichlorotetrafluoroethane  
    hydrochloric acid  
    nitric acid  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17270-504-00 1 in 1 CARTON
    1 300 in 1 INHALER, REFILL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA087907 05/23/1984
    Labeler - Armstrong Pharmaceuticals, Inc. (001185115)
    Establishment
    Name Address ID/FEI Business Operations
    Armstrong Pharmaceuticals, Inc. 001185115 MANUFACTURE
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