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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 onlyAsthma 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 weekThese may be signs that your asthma isgetting 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


OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health care professional before use


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.


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


Primatene MIST® Carton

Principal Display Panel Text:

Primatene MIST®

Epinephrine Inhalation Aerosol0.125 mg per sprayBronchodilatorFor OralInhalation Only

For TEMPORARY reliefof MILD symptomsof INTERMITTENT asthma

Suspension:Shake then Sprayinto the air beforeeach inhalation.

This item is

electronically

protected

NEW FORMULATION:See Important UsageInformation on Insertand on Side Panels

160 Metered SpraysNet Weight: 11.7g