Label: NALOXONE HYDROCHLORIDE spray

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

Drug Label Information

Updated October 3, 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

  • Directions

    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

    Do not test nasal spray device before use

    1 nasal spray device contains 1 dose of medicine

    Each device sprays 1 time only

    		holding nasal spray device
    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

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

    Step 4: WATCH & GIVE

    • WAIT2-3 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 2-3 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 on Naloxone HCl Nasal Spray 4 mg, call Padagis® at 1-866-634-9120 or go to www.padagis.com.

    64Q00 RT QS2

  • Warning

    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

  • 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 Ingredients

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

  • Questions?

    call 1-866-634-9120 or go to www.padagis.com
  • HOW SUPPLIED

    Naloxone HCl Nasal Spray 4 mg

    NDC: 72162-2376-2: 2 Single-Dose Vials in a Carton

    Store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F)

    Repackaged/Relabeled by:
    Bryant Ranch Prepack, Inc.
    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Naloxone HCl 4mg Nasal Spray #2

    Label
    Extended Label
  • INGREDIENTS AND APPEARANCE
    NALOXONE HYDROCHLORIDE 
    naloxone hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72162-2376(NDC:45802-578)
    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)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72162-2376-22 in 1 CARTON10/03/2024
    1NDC:72162-2376-40.1 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
    ANDAANDA21195107/30/2023
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(72162-2376) , RELABEL(72162-2376)
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