PRIMATENE MIST- epinephrine inhalation aerosol

Primatene Mist by

Drug Labeling and Warnings

Primatene Mist by is a Otc medication manufactured, distributed, or labeled by Armstrong Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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® 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.

NEW FORMULATION:
See Important Usage
Information on Insert
and on Side Panels

160 Metered Sprays
Net Weight: 11.7g

INGREDIENTS AND APPEARANCE

PRIMATENE MIST 
epinephrine inhalation aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17270-553
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	125 ug

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
NORFLURANE (UNII: DH9E53K1Y8)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17270-553-00	1 in 1 CARTON	12/14/2018
1		160 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205920	12/14/2018

Labeler - Armstrong Pharmaceuticals, Inc. (809773794)

Establishment
Name	Address	ID/FEI	Business Operations
Armstrong Pharmaceuticals, Inc.		809773794	manufacture(17270-553) , analysis(17270-553) , pack(17270-553)