Prescription Drugs

CLINICAL PHARMACOLOGY No Information Provided.

Primatene® Mist (epinephrine) for Inhalation This product available OTC Warnings Asthma alert: Because asthma can be life threatening, see a doctor if you are not better in 20 minutes get worse need 12 inhalations in any day use more than 9 inhalations a day for more than 3 days a week have more than 2 asthma attacks in a week For Inhalation only DESCRIPTION Drug Facts Active ingredient (in each inhalation) Epinephrine 0.22 mg with the purpose of being a Bronchodilator. Inactive Ingredients ascorbic acid, dehydrated alcohol (34%), dichlorodifluoromethane (CFC 12), dichlorotetrafluoroethane (CFC 114), hydrochloric acid, nitric acid, purified water

INDICATIONS Uses for temporary relief of occasional symptoms of mild asthma wheezing, tightness of chest, shortness of breath DOSAGE AND ADMINISTRATION 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 1 minute. If not relieved, use once more. Do not use again for at least 3 hours. children under 4 years of age: ask a doctor HOW SUPPLIED For Inhalation Only store at room temperature, between 20-25°C (68-77°F) contains no sulfites see insert for mouthpiece use and care instructions © Armstrong Pharmaceuticals, Inc. Questions or Comments? Call 1-8 PRIMATENE or 1-877-462-8363. www.primatene.com

PATIENT INFORMATION Directions for use of Mouthpiece: The Primatene® Mist (epinephrine for inhalation) mouthpiece, which is enclosed in the Primatene® Mist (epinephrine for inhalation) 15 mL size (not the refill size), should be used for inhalation only with Primatene® Mist (epinephrine for inhalation) . Take plastic cap off mouthpiece. (For refills, use mouthpiece from previous purchase.) Take plastic mouthpiece off bottle. Place short end of mouthpiece on bottle. 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. 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. Exhale slowly keeping lips nearly closed. This helps distribute the medication in the lungs. For storage, place long end of mouthpiece back on bottle and cover with plastic cap. Care of Mouthpiece: The Primatene® Mist (epinephrine for inhalation) 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 LaGrange St., West Roxbury, MA 02132. © 2008 Armstrong Pharmaceuticals, Inc.

SIDE EFFECTS When using this product - increased blood pressure or heart rate can occur, which could lead to more serious problems such as heart attack and stroke. Your risk may increase if you take more frequently or more than the recommended dose. - nervousness, sleeplessness, rapid heart beat, tremor, and seizure may occur. If these symptoms persist or get worse, consult a doctor right away. DRUG INTERACTIONS 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)

WARNINGS Asthma alert: Because asthma can be life threatening, see a doctor if you are not better in 20 minutes get worse need 12 inhalations in any day use more than 9 inhalations a day for more than 3 days a week have more than 2 asthma attacks in a week For Inhalation only PRECAUTIONS 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 pharmacist before taking this product. Ask a doctor before use if you have ever been hospitalized for asthma heart disease high blood pressure diabetes thyroid disease seizures narrow angle glaucoma a psychiatric or emotional condition trouble urinating due to an enlarged prostate gland 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 increased blood pressure or heart rate can occur, which could lead to more serious problems such as heart attack and stroke. Your risk may increase if you take more frequently or more than the recommended dose. nervousness, sleeplessness, rapid heart beat, tremor, and seizure may occur. If these symptoms persist or get worse, consult a doctor right away. avoid caffeine-containing foods or beverages. avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect. do not puncture or throw into incinerator. Contents under pressure. do not use or store near open flame or heat above 120°F (49°C). May cause bursting. 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.