Label: NALOXONE HYDROCHLORIDE spray

  • NDC Code(s): 51316-210-01, 51316-210-02
  • Packager: CVS Pharmacy, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 24, 2024

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  • Active ingredient (in each spray)

    Naloxone hydrochloride 4 mg

  • Purpose

    Emergency treatment of opioid overdose

  • Use(s)

    • 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

    step 1

    Step 1: CHECK if you suspect an overdose

    • CHECK for a suspected overdose: the person will not wake up or is very sleepy or not breathing well
    • yell “Wake up!”
    • shake the person gently
    • if the person is not awake, go to Step 2

     

    Step 2

    Step 2: GIVE 1st dose in the nose

    • HOLD the nasal spray device with your thumb on the bottom of the plunger
    • INSERT the nozzle into either NOSTRIL
    • PRESS the plunger firmly to give the 1st dose
    • 1 nasal spray device contains 1 dose

     

    step 3

    Step 3: CALL 911

    • CALL 911 immediately after giving the 1st dose

     

    step 4

    Step 4: WATCH & GIVE

    • WAIT 2 to 3 minutes after the 1st dose to give the medicine time to work
    • if the person wakes up: Go to Step 5
    • if the person does not wake up:
    • CONTINUE TO GIVE doses every 2 to 3 minutes until the person wakes up
    • it is safe to keep giving doses

     

    step 5

    Step 5: STAY

    • STAY until ambulance arrives: even if the person wakes up
    • GIVE another dose if the person becomes very sleepy again
    • You may need to give all the doses in the pack
  • 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
    • this product is packaged in individually-sealed blisters. Do not use if the blister is open or torn, or if the device appears damaged.
  • KEEP OUT OF REACH OF CHILDREN

  • Storage

  • Inactive ingredients

    benzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride

  • Questions

    1-877-835-5472 (Mon-Fri, 9AM-5PM EST)

  • DIRECTIONS

    Naloxone Hydrochloride Nasal Spray, 4 mg

    Emergency Treatment of Opioid Overdose

    Important:

    • For use in the nose only
    • Do not test nasal spray device before use
    • 1 nasal spray device contains 1 dose of medicine
    • Each device sprays 1 time only
    hand drawing
    step 1

    Step 1: CHECK if you suspect an overdose:

    • CHECK for a suspected overdose: the person will not wake up
      or is very sleepy or not breathing well
    • yell “Wake up!”
    • shake the person gently
    • if the person is not awake, go to Step 2
    step 2

    Step 2: GIVE 1st dose in the nose

    • HOLD the nasal spray device with your thumb on the bottom
      of the plunger
    • INSERT the nozzle into either NOSTRIL
    • PRESS the plunger firmly to give the 1st dose
    • 1 nasal spray device contains 1 dose
    step 3

    Step 3: CALL 911

    • CALL 911 immediately after giving the 1st dose
    step 4

    Step 4: WATCH AND GIVE

    • WAIT 2 to 3 minutes after the 1st dose to give the medicine time to work
    • if the person wakes up: Go to Step 5
    • if the person does not wake up:
      • CONTINUE TO GIVE doses every 2 to 3 minutes until the person
        wakes up
      • it is safe to keep giving doses
    step 5

    Step 5: STAY

    • STAY until ambulance arrives: even if the person wakes up
    • GIVE another dose if the person becomes very sleepy again
    • You may need to give all the doses in the pack

    For opioid emergencies, call 911.For questions or more information about Naloxone Hydrochloride Nasal Spray, contact Amneal Pharmaceuticals at 1-877-835-5472.

    Rev. 07-2023-04

  • Principal Display Panel

    ifc
  • INGREDIENTS AND APPEARANCE
    NALOXONE HYDROCHLORIDE 
    naloxone hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-210
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Product Characteristics
    Colorwhite (clear, colorless to faintly yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-210-022 in 1 CARTON04/24/2024
    1NDC:51316-210-010.1 mL in 1 VIAL; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21799204/24/2024
    Labeler - CVS Pharmacy, Inc (062312574)
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