SPL v5
SPL
SPL Set ID 95011f7e-51be-4851-80a6-a7e9c6cad82a
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2024-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Epinephrine (125 ug)
Inactive Ingredients
Alcohol Norflurane Polysorbate 80 Thymol

Identifiers & Packaging

Marketing Status
NDA Active Since 2018-12-14

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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