S2 Racepinephrine MULTI-DOSE Racepinephrine Hydrochloride BENZOIC ACID CHLOROBUTANOL POTASSIUM METABISULFITE PROPYLENE GLYCOL SODIUM CHLORIDE SODIUM METABISULFITE WATER RACEPINEPHRINE HYDROCHLORIDE RACEPINEPHRINE
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 15 ml Bottle Principal Dispay - Primary Container Label (15 mL Amber Glass, Multi-Dose Bottle) NDC 0487-5910-01 Principal Display - Carton (Individual 15 mL Amber Glass, Multi-Dose Bottle) NDC 0487-5910-01 Figure 01 Figure 02
- PRINCIPAL DISPLAY PANEL - 15 ml Bottle Principal Dispay - Primary Container Label (15 mL Amber Glass, Multi-Dose Bottle) NDC 0487-5910-01 Principal Display - Carton (Individual 15 mL Amber Glass, Multi-Dose Bottle) NDC 0487-5910-01 Figure 01 Figure 02
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 Do not use more than directed The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine. For use in a nebulizer: Add 0.5 ml (approximately 10 drops) of solution to nebulizer. Adults and children 4 years of age and over: 1 to 3 inhalations not more often than every 3 hours. Start with one inhalation, then wait at least 1 minute. If symptoms do not improve, use once more. Do not exceed more than 3 inhalations over a 3 hour period. 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. Allergy alert Contains potassium metabisulfite and sodium metabisulfite, sulfites that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. 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, 2.25% is supplied in 15 ml amber glass, multi-dose bottles. NDC 0487-5910-01 15 ml amber glass, multi-dose bottle
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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