NALOXONE HYDROCHLORIDE- naloxone hydrochloride spray 
Amneal Pharmaceuticals NY LLC

----------

Naloxone Hydrochloride Nasal Spray

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

1 check

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
2 give

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
3 call

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
5 stay

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.

Inactive ingredients

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

Questions or comments?

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
1 check

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
2 give

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
3 call

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
5 stay

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
NALOXONE HYDROCHLORIDE 
naloxone hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69238-2104
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:69238-2104-72 in 1 CARTON04/24/2024
1NDC:69238-2104-10.1 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
ANDAANDA21799204/24/2024
Labeler - Amneal Pharmaceuticals NY LLC (123797875)
Establishment
NameAddressID/FEIBusiness Operations
Amneal Pharmaceuticals, LLC079823130analysis(69238-2104) , label(69238-2104) , manufacture(69238-2104) , pack(69238-2104)

Revised: 4/2024
 
Amneal Pharmaceuticals NY LLC