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

S2 (RACEPINEPHRINE HYDROCHLORIDE) SOLUTION [NEPHRON SC, INC.]
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NDC 0487-5901-99
Set ID dd1b35c7-b23b-4b95-8162-df3d263fe32e
Category HUMAN OTC DRUG LABEL
Packager Nephron SC, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
  • 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.

    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

    • 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.
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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, 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.
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  • Inactive Ingredients

    Ascorbic acid, citric acid, edetate disodium, 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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  • PACKAGE LABEL, PRINCIPAL DISPLAY PANEL

    Principle Display - Pouch Label (Individually Wrapped Vial)

    NDC 0487-5901-99

    Figure 01

    Principle Display - Carton (30 Individually Wrapped Vials)

    NDC 0487-5901-99

    Figure 02

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  • INGREDIENTS AND APPEARANCE
    S2 
    racepinephrine hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0487-5901
    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
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0487-5901-99 30 in 1 CARTON 01/01/2000
    1 1 in 1 POUCH
    1 0.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/2000
    Labeler - Nephron SC, Inc. (079160190)
    Establishment
    Name Address ID/FEI Business Operations
    Nephron SC, Inc. 079160190 manufacture(0487-5901) , analysis(0487-5901) , pack(0487-5901) , label(0487-5901)
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