S2

Nephron Pharmaceuticals Corporation
Nephron Pharmaceuticals Corporation

S2® - Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator

FULL PRESCRIBING INFORMATION

Nephron Pharmaceuticals Corporation

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

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.

• 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 an 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.

• ● 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 Hand-held Bulb Nebulizer:

  Racepinephrine inhalation solution does not require dilution

  For use in a Jet Nebulizer:

  One 0.5 mL vial should be diluted to a volume of 3 to 5 mL with sterile 0.9% sodium chloride solution

• ● Adults and children 4 years of age and over:
  • Hand-held Bulb Nebulizer: 1 to 3 inhalations not more often than every 3 hours
  • Jet Nebulizer: Administer for fifteen minutes every 3 to 4 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.

S2® 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.

NDC 0487-5901-10 10 vials, each vial in an individual foil pouch.

NDC 0487-5901-02 30 vials, each vial in an individual foil pouch, robot ready.

Storage and Handling

• ●Protect from light.  Avoid excessive heat. Protect from freezing.
• ●Store between 2° - 25° C (36 and 77°F).

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

Orlando, FL  32811

Principal Display Panel – Foil Pouch

NDC 0487-5901-99

NDC 0487-5901-10

S2® Racepinephrine Inhalation Solution, USP 2.25%

FOR ORAL INHALATION ONLY

Drug Facts

Active Ingredient: Racepinephrine, USP

Each 0.5mL contains 11.25mg (as 13.5mg of Racepinephrine HCl, USP).

Purpose: Bronchodilator

Uses: For temporary relief of mild symptoms of intermittent asthma:

Wheezing, Tightness of chest, Shortness of breath

See product carton for detailed information on Uses, Warnings, and Directions.

Other Information: Store at room temperature, between 2° - 25°C (36°F and 77°F). Protect from light.

Inactive Ingredients: Ascorbic acid, citric acid, edetate disodium, water for injection.

TAMPER EVIDENT FEATURE:

Do not use this product if the pouch is damaged or torn.

Do not use this product if it is brown in color or cloudy.

STERILE

One 0.5mL Unit-of-Use Vial

Principal Display Panel – Carton (30 individually wrapped vials)

NDC 0487-5901-99

S2® Racepinephrine Inhalation Solution, USP 2.25%

Bronchodilator

FOR ORAL INHALATION ONLY

TAMPER EVIDENT FEATURE:

Do not use this product if the pouch is damaged or torn.

SULFITE-FREE

PRESERVATIVE-FREE

Nephron Pharmaceuticals Corporation

Orlando, FL 32811

30x 0.5mL Sterile Unit-of-Use Vials, each in a foil pouch.

Principal Display Panel – Carton (10 individually wrapped vials)

NDC 0487-5901-10

S2® Racepinephrine Inhalation Solution, USP 2.25%

Bronchodilator

FOR ORAL INHALATION ONLY

TAMPER EVIDENT FEATURE:

Do not use this product if the pouch is damaged or torn.

SULFITE-FREE

PRESERVATIVE-FREE

Nephron Pharmaceuticals Corporation

Orlando, FL 32811

10x 0.5mL Sterile Unit-of-Use Vials, each in a foil pouch.