PRIMATENE MIST- epinephrine inhalation aerosol 
Armstrong Pharmaceuticals, Inc.


Active ingredient (in each spray)

Epinephrine 0.125 mg




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


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.


■ 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
For Oral
Inhalation Only

For TEMPORARY relief
of MILD symptoms

Shake then Spray
into the air before
each inhalation.

This item is



See Important Usage
Information on Insert
and on Side Panels

160 Metered Sprays
Net Weight: 11.7g


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
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
#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
Labeler - Armstrong Pharmaceuticals, Inc. (809773794)
NameAddressID/FEIBusiness Operations
Armstrong Pharmaceuticals, Inc.809773794manufacture(17270-553) , analysis(17270-553) , pack(17270-553)

Revised: 6/2021
Document Id: dfc294ab-2065-4da8-b508-84f1a5d7785b
Set id: 95011f7e-51be-4851-80a6-a7e9c6cad82a
Version: 3
Effective Time: 20210603
Armstrong Pharmaceuticals, Inc.