S2 racepinephrine hydrochloride ASCORBIC ACID CITRIC ACID MONOHYDRATE EDETATE DISODIUM WATER RACEPINEPHRINE HYDROCHLORIDE RACEPINEPHRINE
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel S 2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 1 x 0.5 mL Sterile Unit-of-use Vial Each in a foil pouch bag label
- Principal Display Panel S 2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 1 x 0.5 mL Sterile Unit-of-use Vial Each in a foil pouch bag label
Overview
Uses For temporary relief of mild symptoms of intermittent asthma: • Wheezing • Tightness of chest • Shortness of breath
Indications & Usage
Uses For temporary relief of mild symptoms of intermittent asthma: • Wheezing • Tightness of chest • Shortness of breath
Dosage & Administration
Directions • The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine. • Do not use more than directed • For use in a hand-held rubber bulb nebulizer: Add 0.5 ml (contents of one vial) of solution to nebulizer. • Adults and children 4 years of age and over: 1 to 3 inhalations not more often than every 3 hours. Do not use more than 12 inhalations in 24 hours. The use of this product by children should be supervised by an adult. • Children under 4 years of age: ask a doctor.
Warnings & Precautions
Warnings Asthma alert Because asthma may be life threatening, see a doctor if you: • Are not better in 20 minutes • Get worse • Need more than 12 inhalations in 24 hours • Use more than 9 inhalations in 24 hours for 3 or more days a week • 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 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 a MAOI, ask a doctor or pharmacist before taking this product. • If product is brown in color or cloudy 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). Stop use and ask a doctor if: • Your asthma is getting worse (See Asthma alert ) • You have difficulty sleeping • You have a rapid heartbeat • You have tremors, nervousness, or seizure 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. • 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.
Purpose
Purpose Bronchodilator
Do Not Use
Do not use: • Unless a doctor said you have asthma • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs 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 a MAOI, ask a doctor or pharmacist before taking this product. • If product is brown in color or cloudy
When Using
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.
Stop Use & Ask a Doctor
Stop use and ask a doctor if: • Your asthma is getting worse (See Asthma alert ) • You have difficulty sleeping • You have a rapid heartbeat • You have tremors, nervousness, or seizure
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.
Storage & Handling
Other Information • Protect from light. Avoid excessive heat. Protect from freezing. • Store between 2°C and 25°C (36°F and 77°F). • How Supplied: S 2 ® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials. Available overbagged with 1 x 0.5 mL Sterile Unit-Of-Use Vial, each vial in an individual foil pouch, NDC 55154-4352-8
Questions
Questions? 1-800-443-4313 Monday through Friday, 8:00 a.m. to 5:00 p.m. (Eastern Standard Time).
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