Label: PHENYLEPHRINE HCL injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 14, 2015

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  • PRINCIPAL DISPLAY PANEL

    Preparation Label

  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    PHENYLEPHRINE HCL 
    phenylephrine hcl injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-110
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride160 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X) 9.056 mg  in 1 mL
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 64 ug  in 1 mL
    SODIUM METABISULFITE (UNII: 4VON5FNS3C) 32 ug  in 1 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 14.6 ug  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52533-110-18250 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/30/2011
    Labeler - Cantrell Drug Company (035545763)