Primatene

Name: Primatene

Primatene Overview

Primatene is a brand name medication included in the following groups of medications: Adrenergic and dopaminergic agents, Sympathomimetics excl. antiglaucoma preparations, Sympathomimetics, combinations excl. corticosteroids, Sympathomimetics, plain, Expectorants. For more information about Primatene see its generics Ephedrine, Guaifenesin

Manufacturer

  • Pfizer Consumer Healthcare

  • Wyeth Consumer Healthcare

Primatene® MIST

Primatene® Mist (CFC) will not be available after December 31, 2011.
Talk to your doctor and/or pharmacist about other asthma medicines.

Drug Facts

Directions

  • do not exceed dosage
  • supervise children using this product
  • adults and children 4 years and over: start with one inhalation, then wait at least 1minute. If not relieved, use once more. Do not use again for at least 3 hours.
  • children under 4 years of age: ask a doctor

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

Primatene® Mist (CFC) will not be available after December 31, 2011.
Talk to your doctor and/or pharmacist about other asthma medicines.

1/2 FL OZ (15 mL)

Primatene MIST 
epinephrine inhalant
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:17270-503
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Epinephrine (Epinephrine) Epinephrine 0.22 mg
Inactive Ingredients
Ingredient Name Strength
Ascorbic Acid  
alcohol  
dichlorodifluoromethane  
dichlorotetrafluoroethane  
hydrochloric acid  
nitric acid  
water  
Packaging
# Item Code Package Description
1 NDC:17270-503-00 1 INHALER (INHALER) in 1 CARTON
1 300 INHALANT (SPRAY) in 1 INHALER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087907 05/23/1984
Primatene MIST REFILL 
epinephrine inhalant
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:17270-504
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Epinephrine (Epinephrine) Epinephrine 0.22 mg
Inactive Ingredients
Ingredient Name Strength
Ascorbic Acid  
alcohol  
dichlorodifluoromethane  
dichlorotetrafluoroethane  
hydrochloric acid  
nitric acid  
water  
Packaging
# Item Code Package Description
1 NDC:17270-504-00 1 INHALER, REFILL (INHALER, REFILL) in 1 CARTON
1 300 INHALANT (SPRAY) in 1 INHALER, REFILL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087907 05/23/1984
Labeler - Armstrong Pharmaceuticals, Inc. (001185115)
Establishment
Name Address ID/FEI Operations
Armstrong Pharmaceuticals, Inc. 001185115 MANUFACTURE
Revised: 07/2010   Armstrong Pharmaceuticals, Inc.

For the Consumer

Applies to epinephrine: injection injectable, injection solution

Along with its needed effects, epinephrine (the active ingredient contained in Primatene Mist) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking epinephrine:

Incidence not known
  • Abnormal or decreased touch sensation
  • anxiety
  • arm, back, or jaw pain
  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • blurred vision
  • chest pain or discomfort
  • chest tightness or heaviness
  • cold, pale, or bluish color of the skin of the fingers or toes
  • dizziness
  • fainting
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • fear or nervousness
  • headache
  • nausea or vomiting
  • numbness, tingling, or pain in the fingers
  • paleness of the skin
  • pounding in the ears
  • restlessness
  • shakiness in the legs, arms, hands, or feet
  • stroke
  • sweating
  • trembling or shaking of the hands or feet
  • troubled breathing
  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking epinephrine:

Symptoms of overdose
  • Agitation
  • coldness of the skin
  • coma
  • confusion
  • decreased awareness or responsiveness
  • decreased urine output
  • depression
  • drowsiness
  • hostility
  • irritability
  • lightheadedness, dizziness, fainting
  • muscle twitching
  • rapid weight gain
  • rapid, deep breathing
  • seizures
  • severe sleepiness
  • stomach cramps
  • swelling of the face, ankles, or hands
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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