Label: NARCAN NALOXONE HCL spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 20, 2024

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  • ACTIVE INGREDIENT (IN EACH SPRAY)

    Naloxone Hydrochloride 4 mg

  • PURPOSE

    Emergency treatment of opioid overdose

  • USES

    • to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin
    • this medicine can save a life
  • WARNINGS

    When using this product some people may experience symptoms when they wake up, such as, shaking, sweating, nausea, or feeling angry. This is to be expected.

  • DIRECTIONS

    Directions

    Directions

    For opioid emergencies, call 911. For questions on NARCAN, call 1-844-4NARCAN (1-844-462-7226) or go to WWW.NARCAN.COM.

    ©2023 Emergent Devices Inc. EMERGENT® and NARCAN® are registered trademarks of Emergent BioSolutions Inc, or its subsidiaries.

    Other Information

    •
    store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F)
    •
    do not freeze
    •
    avoid excessive heat above 40°C (104°F)
    •
    protect from light
    •
    the product is packaged in individually-sealed blisters.

    Do not use if the blister is open or torn, or if the device appears damaged.

  • INACTIVE INGREDIENT

    benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water

  • QUESTIONS

    Call 1-844-4NARCAN (1-844-462-7226) or go to WWW.NARCAN.COM

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PRINCIPAL DISPLAY PANEL- CARTON LABEL

    CARTON LABEL

  • PRINCIPAL DISPLAY PANEL_ NDC 51662-1642-1

    pack

    RFID Label

  • PRINCIPAL DISPLAY PANEL- NDC 51662-1642-2

    pack

    RFID Label

  • INGREDIENTS AND APPEARANCE
    NARCAN NALOXONE HCL 
    narcan naloxone hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51662-1642(NDC:69547-627)
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N) NALOXONE HYDROCHLORIDE4 mg  in 0.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51662-1642-22 in 1 CARTON08/28/2023
    1NDC:51662-1642-10.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20841108/28/2023
    Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)
    Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)
    Establishment
    NameAddressID/FEIBusiness Operations
    HF Acquisition Co LLC, DBA HealthFirst045657305relabel(51662-1642)
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