Primatene Mist
Epinephrine Inhalation · Aerosol · Respiratory (inhalation)
Active ingredient
Active ingredient (in each spray) Epinephrine 0.125 mg
Purpose
Purpose Bronchodilator
Uses
Uses for temporary relief of mild symptoms of intermittent asthma ■ wheezing ■ tightness of chest ■ shortness of breath
Warnings
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.
Do not use
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
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
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
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
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
Pregnancy or breast-feeding
If pregnant or breast-feeding , ask a health care professional before use
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
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
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
Inactive ingredients dehydrated alcohol (1%), hydrofluoroalkane (HFA 134a), polysorbate 80, thymol
Questions?
Questions or comments? call 1-8 Primatene or 1-877-462-8363 Mon.- Fri. 7 am - 5 pm PST
Label text from the FDA structured product label by Armstrong Pharmaceuticals, Inc. (revised Jun 16, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Epinephrine in 2 products
Primatene Mist NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 17270-5512 | Epinephrine 125 ug/1 Aerosol | Armstrong Pharmaceuticals, Inc. | NDA |
| 17270-5530 | Epinephrine 125 ug/1 Aerosol | Armstrong Pharmaceuticals, Inc. | NDA |
Frequently asked questions
What is Primatene Mist used for?
Uses for temporary relief of mild symptoms of intermittent asthma ■ wheezing ■ tightness of chest ■ shortness of breath
Who makes Primatene Mist?
Primatene Mist is listed by 1 labeler in the FDA NDC directory, including Armstrong Pharmaceuticals, Inc..