Primatene Mist

Primatene Mist is an FDA-registered drug product whose active ingredient is EPINEPHRINE INHALATION. It is labelled by Armstrong Pharmaceuticals, Inc. taken by respiratory (inhalation) and marketed as a human otc drug product. Identifiers on file: NDC 17270-5512, application NDA205920, label effective 20260616. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing EPINEPHRINE INHALATION are most often described in connection with: temporary relief, mild symptoms, intermittent asthma, wheezing tightness, chest shortness. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses for temporary relief of mild symptoms of intermittent asthma ■ wheezing ■ tightness of chest ■ shortness of breath

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.

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.

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?
Armstrong Pharmaceuticals, Inc. is the labeler of record for Primatene Mist.

What form does Primatene Mist come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Primatene Mist prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Primatene Mist been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.