S2

Drug Facts

Racepinephrine, USP 11.25 mg (as 13.5 mg of Racepinephrine HCl, USP).

Bronchodilator

For temporary relief of mild symptoms of intermittent asthma:

• Wheezing
• Tightness of chest
• Shortness of breath

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.

Label information

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
• If its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Label information

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

Label information

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).

Label information

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

Label information

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.

Label information

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

Label information

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

• 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.

• 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.
  
  NDC 0487-5901-99 30 vials, each vial in an individual foil pouch.

Ascorbic acid, citric acid, edetate disodium, water for injection.

1-800-443-4313

Monday through Friday, 8:00 a.m. to 5:00 p.m. (Eastern Standard Time).

Manufactured By:

Nephron Pharmaceuticals Corporation

West Columbia, SC 29172

Principle Display - Pouch Label (Individually Wrapped Vial)

NDC 0487-5901-99

[Image in the official label — see DailyMed source]

Principle Display - Carton (30 Individually Wrapped Vials)

NDC 0487-5901-99

[Image in the official label — see DailyMed source]