Primatene® MIST

PRIMATENE MIST - epinephrine inhalant 
PRIMATENE MIST REFILL - epinephrine inhalant 
Armstrong Pharmaceuticals, Inc.

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Primatene®
MIST

Drug Facts

Active ingredient (in each inhalation)

Epinephrine 0.22 mg

Purpose

Bronchodilator

Uses

Warnings

Asthma alert

Because asthma can be life threatening, see a doctor if you

For inhalation only

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Contains CFC 12, 114, substances which harm public health and environment by destroying ozone in the upper atmosphere.

If pregnant or breast-feeding, ask a health 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

Other information

Inactive ingredients

ascorbic acid, dehydrated alcohol (34%), dichlorodifluoromethane (CFC 12), dichlorotetrafluoroethane (CFC 114), hydrochloric acid, nitric acid, purified water

Questions or comments?

call 1-8 PRIMATENE or 1-877-462-8363

DIRECTIONS FOR USE OF MOUTHPIECE

The Primatene Mist mouthpiece, which is enclosed in the Primatene Mist 15 mL size (not the refill size), should be used for inhalation only with Primatene Mist.

1. Take plastic cap off mouthpiece. (For refills, use mouthpiece from previous purchase.)Figure
2. Take plastic mouthpiece off bottle.Figure
3. Place short end of mouthpiece on bottle.Figure
4. Turn bottle upside down. Place thumb on bottom of mouthpiece over circular button and forefinger on top of vial. Empty the lungs as completely as possible by exhaling.Figure
5. Place mouthpiece in mouth with lips closed around opening. Inhale deeply while squeezing mouthpiece and bottle together. Release immediately and remove unit from mouth, then complete taking the deep breath, drawing medication into your lungs, holding breath as long as comfortable.Figure
6. Exhale slowly keeping lips nearly closed. This helps distribute the medication in the lungs.Figure
7. For storage, place long end of mouthpiece back on bottle and cover with plastic cap.Figure

CARE OF THE MOUTHPIECE

The Primatene Mist mouthpiece should be washed after each use with hot, soapy water, rinsed thoroughly, and dried with a clean, lint-free cloth.

If the unit becomes clogged and fails to spray, please write and send the clogged unit to:
Armstrong Pharmaceuticals, Inc., 423 La Grange Street, West Roxbury, MA 02132

PRINCIPAL DISPLAY PANEL - 15 mL Carton

Primatene®
MIST

Epinephrine Inhalation Aerosol Bronchodilator

For the Temporary Relief of
BRONCHIAL ASTHMA

WITH MOUTHPIECE FOR ORAL INHALATION
1/2 FL OZ (15 mL)

Principal Display Panel - 15 mL Carton

PRINCIPAL DISPLAY PANEL - 15 mL Refill Carton

Primatene®
MIST

Epinephrine Inhalation Aerosol Bronchodilator

For the Temporary Relief of
BRONCHIAL ASTHMA

INHALER
REFILL

USE WITH
PRIMATENE
MOUTHPIECE

1/2 FL OZ (15 mL)

Principal Display Panel - 15 mL Refill Carton

PRIMATENE MIST 
epinephrine   inhalant
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)17270-503
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Epinephrine (Epinephrine) Epinephrine0.22 mg
Inactive Ingredients
Ingredient NameStrength
Ascorbic Acid 
alcohol 
dichlorodifluoromethane 
dichlorotetrafluoroethane 
hydrochloric acid 
nitric acid 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
117270-503-001 INHALER In 1 CARTONcontains a INHALER
1300 SPRAY In 1 INHALERThis package is contained within the CARTON (17270-503-00)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08790705/23/1984

PRIMATENE MIST REFILL 
epinephrine   inhalant
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)17270-504
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Epinephrine (Epinephrine) Epinephrine0.22 mg
Inactive Ingredients
Ingredient NameStrength
Ascorbic Acid 
alcohol 
dichlorodifluoromethane 
dichlorotetrafluoroethane 
hydrochloric acid 
nitric acid 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
117270-504-001 INHALER, REFILL In 1 CARTONcontains a INHALER, REFILL
1300 SPRAY In 1 INHALER, REFILLThis package is contained within the CARTON (17270-504-00)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08790705/23/1984

Labeler - Armstrong Pharmaceuticals, Inc. (001185115)
Establishment
NameAddressID/FEIOperations
Armstrong Pharmaceuticals, Inc.001185115MANUFACTURE
Revised: 10/2009Armstrong Pharmaceuticals, Inc.