Label: NALOXONE HYDROCHLORIDE spray

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

Drug Label Information

Updated March 10, 2025

If you are a consumer or patient please visit this version.

  • 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

    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

    holding nasal spray device
    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.

  • 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
  • Package/Label Principal Display Panel

    Good Neighbor Pharmacy

    NDC 46122-812-71

    Original Prescription Strength

    Naloxone HCl Nasal Spray 4 mg

    Emergency Treatment of Opioid Overdose

    Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency

    Easy to Use

    Can Save a Life

    For use in nose only

    2 SINGLE-DOSE NASAL SPRAY DEVICES

    0.003 FL OZ (0.1mL) EACH

    Safe to Use Even if Opioids are Not Present

    *Good Neighbor Pharmacy® Naloxone HCl Nasal Spray 4 mg is not manufactured or distributed by Emergent Operations Ireland Limited.

    Distributed By AmerisourceBergen

    1 West First Avenue,

    Conshohocken, PA 19428

    Questions or Concerns?

    www.mygnp.com

    Manufactured by Padagis®

    Yeruham, Israel

    Product of France

    64QJ8 GP C1

    64Q00 RT QS2

    Naloxone HCl Nasal Spray 4 mg carton with directions
  • INGREDIENTS AND APPEARANCE
    NALOXONE HYDROCHLORIDE 
    naloxone hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-812
    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:46122-812-712 in 1 CARTON03/12/2025
    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
    ANDAANDA21195103/12/2025
    Labeler - AMERISOURCE BERGEN (007914906)