Label: MORPHINE SULFATE - morphine sulfate injection, solution

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

Drug Label Information

Updated 08/15

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  • Label
  • • 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 50 mL (50 mg) of Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride in a 50 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:52533-160-04 50 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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