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Over-the-counter medicine · no prescription needed

Epinephrine

Purpose on the label: Bronchodilator

Other medicines

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Epinephrine used for?
The Drug Facts label of Primatene Mist (Armstrong Pharmaceuticals, Inc.) lists these uses: for temporary relief of mild symptoms of intermittent asthma; wheezing; tightness of chest; shortness of breath.
Do I need a prescription for Epinephrine?
No, the products on this page are sold without a prescription. Other products with the same active ingredient need a prescription (often a higher strength or another form): see the prescription page.
Is a store brand the same as the name brand?
Products listed together below have the same active ingredient, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
Has Epinephrine been recalled?
No recall linked to these products appears in the FDA enforcement reports we use.

Also sold by prescription (often at a higher strength or in another form): Epinephrine — prescription medicine

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

Primatene Mist · Armstrong Pharmaceuticals, Inc.

Epinephrine 125 ug, aerosol (respiratory (inhalation))

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.

Inactive ingredients

dehydrated alcohol (1%), hydrofluoroalkane (HFA 134a), polysorbate 80, thymol

Questions?

call 1-8 Primatene or 1-877-462-8363 Mon.- Fri. 7 am - 5 pm PST

— FDA label of Primatene Mist, Armstrong Pharmaceuticals, Inc., effective June 16, 2026. See the official label on DailyMed →

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredient, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Epinephrine 125 ug · aerosol (respiratory (inhalation)) · 2 products

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Primatene Mist Armstrong Pharmaceuticals, Inc. DailyMed

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

Recalls

No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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