NDC 17270-553 Primatene Mist
Epinephrine Inhalation Aerosol Respiratory (inhalation)

Product Information

Product Code17270-553
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Primatene Mist
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Epinephrine Inhalation
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormAerosol - A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols).
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Armstrong Pharmaceuticals, Inc.
Labeler Code17270
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA205920
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-14-2018
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2022
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 17270-553-00

Package Description: 1 INHALER in 1 CARTON > 160 AEROSOL in 1 INHALER

Product Details

Primatene Mist is a human over the counter drug product labeled by Armstrong Pharmaceuticals, Inc.. The generic name of Primatene Mist is epinephrine inhalation. The product's dosage form is aerosol and is administered via respiratory (inhalation) form.


What are Primatene Mist Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • NORFLURANE (UNII: DH9E53K1Y8)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • THYMOL (UNII: 3J50XA376E)


Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.


* Please review the disclaimer below.

Primatene Mist Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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 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


* Please review the disclaimer below.