NALOXONE HYDROCHLORIDE- naloxone hydrochloride spray 
Advanced Rx of Tennessee, LLC

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Naloxone HCl Nasal Spray

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 medicationsor street drugs such as heroin

this medicine can save a life

Keep out of reach of children.

Directions

Step 1

Step 1: CHECK if you suspect an overdose:

CHECKfor 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

HOLDthe nasal spray device with your thumb on the bottom of the plunger

INSERTthe nozzle into either NOSTRIL

PRESSthe 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 GIVEdoses every 2-3 minutes until the person wakes up

    it is safe to keep giving doses

Step 5

Step 5: STAY

STAYuntil ambulance arrives: even if the person wakes up

GIVEanother dose if the person becomes very sleepy again

You may need to give all the doses in the pack

Warning

When using this productsome 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?

Package/Label Principal Display Panel

NDC: 80425-0409-01

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

Naloxone HCl Nasal Spray #2

NALOXONE HYDROCHLORIDE 
naloxone hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0409(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:80425-0409-12 in 1 CARTON06/27/2024
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
ANDAANDA21195106/27/2024
Labeler - Advanced Rx of Tennessee, LLC (117023142)
Establishment
NameAddressID/FEIBusiness Operations
Advanced Rx of Tennessee, LLC117023142repack(80425-0409)

Revised: 6/2024
Document Id: 1be2d8f6-f643-69a6-e063-6294a90a327f
Set id: 1be2e38b-55ca-abea-e063-6394a90ac548
Version: 1
Effective Time: 20240627
 
Advanced Rx of Tennessee, LLC