S2 description, usages, side effects, indications, overdosage, supplying and lots more!

S2

Nephron Pharmaceuticals Corporation
Nephron Pharmaceuticals Corporation

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
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.

S2

racepinephrine hydrochloride SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0487-5901
Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RACEPINEPHRINE HYDROCHLORIDE RACEPINEPHRINE 11.25 mg

Inactive Ingredients

Ingredient Name Strength
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 0.5 in 1 VIAL, SINGLE-USE
2 0.5 in 1 VIAL, SINGLE-USE
3 0.5 in 1 VIAL, SINGLE-USE
4 1 in 1 POUCH
5 NDC:0487-5901-10 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1991-08-21


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