Label: MORPHINE SULFATE - morphine sulfate injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 17, 2015

If you are a consumer or patient please visit this version.

  • • WARNINGS AND PRECAUTIONS

    Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.

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  • • ADVERSE EVENTS

    To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.

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  • • HOW SUPPLIED

    Contains 30 mL (30 mg) of Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride in a 30 mL Single-Dose Syringe.

    This product is Sterile, Nonpyrogenic, Preservative Free, Isotonic, and Latex Free.

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  • • INGREDIENTS

    Each mL contains Morphine Sulfate 1 mg, Sodium Chloride 9 mg. May contain Sulfuric Acid and/or Sodium Hydroxide for pH adjustment.

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  • • STORAGE AND HANDLING

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from freezing. Protect from Light.

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  • • DOSAGE AND ADMINISTRATION.

    FOR SLOW INTRAVENOUS USE. PRESERVATIVE FREE INJECTION SOLUTION.

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  • Rx Only

    Rev. 08/15

    CANTRELL DRUG COMPANY

    LITTLE ROCK, AR 72207

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  • INGREDIENTS AND APPEARANCE
    MORPHINE SULFATE 
    morphine sulfate injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-160
    Route of Administration INTRAVENOUS DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C) MORPHINE SULFATE 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Chloride (UNII: 451W47IQ8X) 9 mg  in 1 mL
    Water (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    May contain SULFURIC ACID (UNII: O40UQP6WCF)  
    May contain SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52533-160-03 30 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 08/17/2015
    Labeler - Cantrell Drug Company (035545763)
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