Label: EPINEPHRINE PROFESSIONAL EMS- epinephrine convenience kit kit

  • NDC Code(s): 24357-012-12, 42023-159-01, 68599-5804-1
  • Packager: Focus Health Group
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 23, 2019

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  • DOSAGE & ADMINISTRATION

    Dosage and Administration:

    Always follow the prescriber’s order for dosing and administration.

    Adrenamine may be administered for anaphylaxis:

    o Adults and Children 30 kg (66 lbs) or more: 0.3 to 0.5 mg (0.3 to 0.5 mL) intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary

    o Children 30 kg (66 lbs) or less: 0.01 mg/kg (0.01 mL/kg), up to 0.3 mg (0.3 mL), intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary

  • PRINCIPAL DISPLAY PANEL

    Epinephrine Professional EMS

  • INGREDIENTS AND APPEARANCE
    EPINEPHRINE PROFESSIONAL EMS 
    epinephrine convenience kit kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24357-012
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24357-012-121 in 1 CARTON; Type 0: Not a Combination Product07/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL 1 mL
    Part 24 PACKET 4 mL
    Part 1 of 2
    ADRENALIN 
    epinephrine injection
    Product Information
    Item Code (Source)NDC:42023-159
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM METABISULFITE (UNII: 4VON5FNS3C) 0.457 mg  in 1 mL
    TARTARIC ACID (UNII: W4888I119H) 2.25 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 1 mg  in 1 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 7.3 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42023-159-011 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20420007/01/2013
    Part 2 of 2
    MCKESSON ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC:68599-5804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-5804-11 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/09/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20420007/01/2019
    Labeler - Focus Health Group (826939949)
    Registrant - Focus Health Group (826939949)
    Establishment
    NameAddressID/FEIBusiness Operations
    Par Sterile Products LLC808402890manufacture(42023-159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Focus Health Group826939949manufacture(24357-012)