S2: Package Insert and Label Information

S2 — racepinephrine hydrochloride solution
Nephron Pharmaceuticals Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient (in each 0.5 ml)

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

Purpose

Bronchodilator

Uses

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.

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.

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 (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. 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.

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: 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.

Inactive Ingredients

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

Questions?

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 — 0.5 mL Vial Pouch Carton

S2®

NDC 0487-5901-99

Racepinephrine
Inhalation Solution, USP 2.25%

Bronchodilator

FOR ORAL INHALATION ONLY

SULFITE-FREE
PRESERVATIVE-FREE

Manufactured By:

nephron
pharmaceuticals
corporation

Orlando, FL 32811

MADE
IN THE USA

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

Principal Display Panel -- 0.5 mL Vial Pouch Carton
(click image for full-size original)
S2 racepinephrine hydrochloride solution
Product Information
Product Type HUMAN OTC DRUG 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) RACEPINEPHRINE 11.25 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0487-5901-99 30 POUCH in 1 CARTON contains a POUCH
1 1 VIAL, SINGLE-USE in 1 POUCH This package is contained within the CARTON (0487-5901-99) and contains a VIAL, SINGLE-USE
1 0.5 mL in 1 VIAL, SINGLE-USE This package is contained within a POUCH and a CARTON (0487-5901-99)
2 NDC:0487-5901-02 30 BAG in 1 BOX contains a BAG
2 1 POUCH in 1 BAG This package is contained within the BOX (0487-5901-02) and contains a POUCH
2 1 VIAL, SINGLE-USE in 1 POUCH This package is contained within the BAG and contains a VIAL, SINGLE-USE
2 0.5 mL in 1 VIAL, SINGLE-USE This package is contained within a POUCH and a BAG and a BOX (0487-5901-02)
3 NDC:0487-5901-10 10 POUCH in 1 CARTON contains a POUCH
3 1 VIAL, SINGLE-USE in 1 POUCH This package is contained within the CARTON (0487-5901-10) and contains a VIAL, SINGLE-USE
3 0.5 mL in 1 VIAL, SINGLE-USE This package is contained within a POUCH and a CARTON (0487-5901-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 01/01/2000
Labeler — Nephron Pharmaceuticals Corporation (783905201)
Registrant — Nephron Pharmaceuticals Corporation (783905201)
Establishment
Name Address ID/FEI Operations
Nephron Pharmaceuticals Corporation 783905201 MANUFACTURE (0487-5901), ANALYSIS (0487-5901), PACK (0487-5901)

Revised: 09/2014 Nephron Pharmaceuticals Corporation

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