NALOXONE HYDROCHLORIDE- naloxone hydrochloride spray 
Padagis Israel Pharmaceuticals Ltd

----------

Naloxone HCl Nasal Spray Drug Facts

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

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

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

NDC 45802-578-84

Naloxone HCl Nasal Spray 4 mg

Emergency Treatment of Opioid Overdose

Original Prescription Strength

Easy to Use

Can Save a Life

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

For use in nose only

2 Single-Dose Nasal Spray Devices

0.003 fl oz (0.1mL) each

carton
NALOXONE HYDROCHLORIDE 
naloxone hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:45802-578-842 in 1 CARTON07/30/2023
1NDC:45802-578-000.1 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 - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 7/2023
Document Id: b5d40220-f194-4835-b70c-f304ecb222d5
Set id: b5d40220-f194-4835-b70c-f304ecb222d5
Version: 1
Effective Time: 20230725
 
Padagis Israel Pharmaceuticals Ltd