S2 RACEPINEPHRINE MULTI-DOSE (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON SC, INC.]

S2 RACEPINEPHRINE MULTI-DOSE (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON SC, INC.]
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NDC 0487-5910-01
Set ID 5c6d98fe-3e86-4816-92f2-49d38a432e39
Category HUMAN OTC DRUG LABEL
Packager Nephron SC, Inc.
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each 0.5 ml)

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

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  • Purpose

    Bronchodilator

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  • Uses

    For temporary relief of mild symptoms of intermittent asthma:

    • Wheezing
    • Tightness of chest
    • Shortness of breath
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  • 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.

    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 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.
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  • 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 (approximately 10 drops) 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.
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  • 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: S 2® 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
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  • Inactive Ingredients

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

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  • Questions?

    1-800-443-4313

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

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  • SPL UNCLASSIFIED SECTION

    Manufactured By:

    Nephron Pharmaceuticals Corporation

    West Columbia, SC 29172

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  • PRINCIPAL DISPLAY PANEL - 15 ml Bottle

    Principal Dispay - Primary Container Label (15 mL Amber Glass, Multi-Dose Bottle)

    NDC 0487-5910-01

    Figure 01

    Principal Display - Carton (Individual 15 mL Amber Glass, Multi-Dose Bottle)

    NDC 0487-5910-01

    Figure 02

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  • INGREDIENTS AND APPEARANCE
    S2 RACEPINEPHRINE  MULTI-DOSE
    racepinephrine hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0487-5910
    Route of Administration RESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RACEPINEPHRINE HYDROCHLORIDE (UNII: 336096P2WE) (RACEPINEPHRINE - UNII:GR0L9S3J0F) RACEPINEPHRINE 11.25 mg  in 0.5 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CHLOROBUTANOL (UNII: HM4YQM8WRC)  
    POTASSIUM METABISULFITE (UNII: 65OE787Q7W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0487-5910-01 1 in 1 CARTON 08/12/1992
    1 15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Export only 08/12/1992
    Labeler - Nephron SC, Inc. (079160190)
    Establishment
    Name Address ID/FEI Business Operations
    Nephron SC, Inc. 079160190 manufacture(0487-5910) , analysis(0487-5910) , pack(0487-5910) , label(0487-5910)
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