95011f7e-51be-4851-80a6-a7e9c6cad82a
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Epinephrine 0.125 mg
Purpose
Bronchodilator
Medication Information
Purpose
Bronchodilator
Description
Epinephrine 0.125 mg
Uses
for temporary relief of mild symptoms of intermittent asthma
■ wheezing
■ tightness of chest
■ shortness of breath
Section 50565-1
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 53414-9
If pregnant or breast-feeding, ask a health care professional before use
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.
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.
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.
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
Bronchodilator
For Oral
Inhalation Only
For TEMPORARY relief
of MILD symptoms
of INTERMITTENT asthma
Suspension:
Shake then Spray
into the air before
each inhalation.
This item is
electronically
protected
NEW FORMULATION:
See Important Usage
Information on Insert
and on Side Panels
160 Metered Sprays
Net Weight: 11.7g
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
Active Ingredient (in Each Spray)
Epinephrine 0.125 mg
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)
Structured Label Content
Uses
for temporary relief of mild symptoms of intermittent asthma
■ wheezing
■ tightness of chest
■ shortness of breath
Section 50565-1 (50565-1)
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health care professional before use
Purpose
Bronchodilator
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.
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.
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.
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 Or Comments? (Questions or comments?)
call 1-8 Primatene or 1-877-462-8363
Mon.- Fri. 7 am - 5 pm PST
Primatene Mist® Carton (Primatene MIST® Carton)
Principal Display Panel Text:
Primatene MIST®
Epinephrine Inhalation Aerosol
0.125 mg per spray
Bronchodilator
For Oral
Inhalation Only
For TEMPORARY relief
of MILD symptoms
of INTERMITTENT asthma
Suspension:
Shake then Spray
into the air before
each inhalation.
This item is
electronically
protected
NEW FORMULATION:
See Important Usage
Information on Insert
and on Side Panels
160 Metered Sprays
Net Weight: 11.7g
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 If (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
Active Ingredient (in Each Spray) (Active ingredient (in each spray))
Epinephrine 0.125 mg
Ask A Doctor Before Use If You Have (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 (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)
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:25.713895 · Updated: 2026-03-14T23:03:29.554848