DOSAGE & ADMINISTRATION SECTION.

Directions. Do not use more than directedThe ingredient is used in an aqueous solution at concentration equivalent to percent epinephrine.For use in nebulizer:Add 0.5 ml (approximately 10 drops) of solution to nebulizer. Adults and children years of age and over: to inhalations not more often than every hours. Start with one inhalation, then wait at least minute. If symptoms do not improve, use once more. Do not exceed more than inhalations over 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 years of age: ask doctor.. Do not use more than directed. The ingredient is used in an aqueous solution at concentration equivalent to percent epinephrine.. For use in nebulizer:Add 0.5 ml (approximately 10 drops) of solution to nebulizer. Adults and children years of age and over: to inhalations not more often than every hours. Start with one inhalation, then wait at least minute. If symptoms do not improve, use once more. Do not exceed more than inhalations over 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 years of age: ask doctor.

INACTIVE INGREDIENT SECTION.

Inactive Ingredients. Benzoic acid, chlorobutanol, potassium metabisulfite, propylene glycol, sodium chloride, sodium metabisulfite, water for injection.

INDICATIONS & USAGE SECTION.

Uses. For temporary relief of mild symptoms of intermittent asthma:WheezingTightness of chestShortness of breath. Wheezing. Tightness of chest. Shortness of breath.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredient (in each 0.5 ml). Racepinephrine, USP 11.25 mg (as 13.5 mg of Racepinephrine HCl, USP).

OTC - ASK DOCTOR SECTION.

Ask doctor before use if you have. Ever been hospitalized for asthmaHeart diseaseHigh blood pressureDiabetesThyroid diseaseSeizuresNarrow angle glaucomaA psychiatric or emotional conditionTrouble urinating due to an enlarged prostate gland. Ever been hospitalized for asthma. Heart disease. High blood pressure. Diabetes. Thyroid disease. Seizures. Narrow angle glaucoma. psychiatric or emotional condition. Trouble urinating due to an enlarged prostate gland.

OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask 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).. 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).

OTC - DO NOT USE SECTION.

Do not use. Unless doctor said you have asthmaIf you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask doctor or pharmacist before taking this product.If product is brown in color or cloudy. Unless doctor said you have asthma. If you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask doctor or pharmacist before taking this product.. If product is brown in color or cloudy.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.

If pregnant or breast-feeding, ask health professional before use. If pregnant or breast-feeding, ask health professional before use.

OTC - PURPOSE SECTION.

Purpose. Bronchodilator.

OTC - QUESTIONS SECTION.

Questions. 1-800-443-4313Monday through Friday, 8:00 a.m. to 5:00 p.m. (Eastern Standard Time).

OTC - STOP USE SECTION.

Stop use and ask doctor if. Your asthma is getting worse (See Asthma alert) You have difficulty sleepingYou have rapid heartbeatYou have tremors, nervousness, or seizure. Your asthma is getting worse (See Asthma alert) You have difficulty sleeping. You have rapid heartbeat. You have tremors, nervousness, or seizure.

OTC - WHEN USING SECTION.

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 history of high blood pressure or heart diseaseTake this product more frequently or take more than the recommended dose.Avoid foods or beverages that contain caffeineAvoid dietary supplements containing ingredients reported or claimed to have stimulant effect.. Your risk of heart attack or stroke increases if you:Have history of high blood pressure or heart diseaseTake this product more frequently or take more than the recommended dose.Avoid foods or beverages that contain caffeineAvoid dietary supplements containing ingredients reported or claimed to have stimulant effect.. Have 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 stimulant effect.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 15 ml Bottle. Principal Dispay Primary Container Label (15 mL Amber Glass, Multi-Dose Bottle)NDC 0487-5910-01Principal Display Carton (Individual 15 mL Amber Glass, Multi-Dose Bottle) NDC 0487-5910-01. Figure 01. Figure 02.

SPL UNCLASSIFIED SECTION.

Drug Facts.

STORAGE AND HANDLING SECTION.

Other Information. Protect from light. Avoid excessive heat. Protect from freezing.Store between 2C and 25C (36F and 77F).How Supplied: 2 (R) 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 Protect from light. Avoid excessive heat. Protect from freezing.. Store between 2C and 25C (36F and 77F).. How Supplied: 2 (R) 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.

WARNINGS SECTION.

Warnings. Asthma alert. Because asthma may be life threatening, see doctor if you:Are not better in 20 minutesGet worseNeed more than 12 inhalations in 24 hoursUse more than inhalations in 24 hours for or more days weekHave more than asthma attacks in weekThese may be signs that your asthma is getting worse.. Are not better in 20 minutes. Get worse. Need more than 12 inhalations in 24 hours. Use more than inhalations in 24 hours for or more days week. Have more than asthma attacks in week. 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 doctor said you have asthmaIf you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask doctor or pharmacist before taking this product.If product is brown in color or cloudy. Unless doctor said you have asthma. If you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains MAOI, ask doctor or pharmacist before taking this product.. If product is brown in color or cloudy. Ask doctor before use if you have. Ever been hospitalized for asthmaHeart diseaseHigh blood pressureDiabetesThyroid diseaseSeizuresNarrow angle glaucomaA psychiatric or emotional conditionTrouble urinating due to an enlarged prostate gland. Ever been hospitalized for asthma. Heart disease. High blood pressure. Diabetes. Thyroid disease. Seizures. Narrow angle glaucoma. psychiatric or emotional condition. Trouble urinating due to an enlarged prostate gland. Ask 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).. 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 doctor if. Your asthma is getting worse (See Asthma alert) You have difficulty sleepingYou have rapid heartbeatYou have tremors, nervousness, or seizure. Your asthma is getting worse (See Asthma alert) You have difficulty sleeping. You have 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 history of high blood pressure or heart diseaseTake this product more frequently or take more than the recommended dose.Avoid foods or beverages that contain caffeineAvoid dietary supplements containing ingredients reported or claimed to have stimulant effect.. Your risk of heart attack or stroke increases if you:Have history of high blood pressure or heart diseaseTake this product more frequently or take more than the recommended dose.Avoid foods or beverages that contain caffeineAvoid dietary supplements containing ingredients reported or claimed to have stimulant effect.. Have 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 stimulant effect.. If pregnant or breast-feeding, ask health professional before use. If pregnant or breast-feeding, ask health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.