Label: PRIMATENE MIST- epinephrine inhalation aerosol
- NDC Code(s): 17270-553-00
- Packager: Armstrong Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated June 3, 2021
If you are a consumer or patient please visit this version.
- Active ingredient (in each spray)
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
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
■ trouble urinating due to an enlarged prostate gland
■ thyroid disease
■ 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
■ 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.
■ 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
- Inactive ingredients
- Questions or comments?
Primatene MIST® Carton
Principal Display Panel Text:
Epinephrine Inhalation Aerosol
0.125 mg per spray
For TEMPORARY relief
of MILD symptoms
of INTERMITTENT asthma
Shake then Spray
into the air before
This item is
See Important Usage
Information on Insert
and on Side Panels
160 Metered Sprays
Net Weight: 11.7g
INGREDIENTS AND APPEARANCE
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)