NARCAN- naloxone hydrochloride nasal spray 
Emergent Devices Inc.

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NARCAN® Naloxone HCl Nasal Spray 4 mg 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

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.

Directions

NARCAN®
Naloxone HCl 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
Naloxone HCl Nasal Spray 4 mg
 
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 lst dose
 
4. Watch/Give

Step 4: WATCH & GIVE

WAIT 2-3 minutes after the lst 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
 
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 on NARCAN, call 1-844-4NARCAN (1-844-462-7226) or go to www.narcan.com.

©2023 Emergent Devices Inc. EMERGENT® and NARCAN® are registered trademarks of Emergent BioSolutions Inc, or its subsidiaries.

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 1-844-4NARCAN (1-844-462-7226) or go to www.narcan.com

Package/Label Principal Display Panel – Carton Label

Package/Label Principal Display Panel - Carton Label

NARCAN®
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

2 Single-Dose Nasal Spray Devices
0.003 fl oz (0.1 mL) each

For use in
nose only

Distributed by Emergent Devices Inc.
Plymouth Meeting, PA 19462 USA

©2023 Emergent Devices Inc. Plymouth Meeting, PA.
All rights reserved.

NARCAN® is a registered trademark of Emergent Operations
Ireland Limited.

NDC 69547-627-02

Package/Label Principal Display Panel - 4 mg Vial Package

Package/Label Principal Display Panel - 4 mg Vial Package

NDC 69547-627-02

NARCAN®
Naloxone HCl Nasal Spray 4 mg
Emergency Treatment of Opioid Overdose

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
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)

Lot XXXXXX EXP YYYY-MMM

Distributed by Emergent Devices Inc.
Plymouth Meeting, PA 19462 USA                A1160

Package/Label Principal Display Panel – Front and Back Label

Package/Label Principal Display Panel – Front and Back Label

NARCAN®
Naloxone HCl Nasal Spray 4 mg

141357
A1158

FOR USE IN THE NOSE ONLY
NDC 69547-627-02

A1159
Distributed by Emergent Devices, Inc.
Plymouth Meeting, PA 19462, USA
141358

Lot XXXXXX
EXP YYYY-MMM

NARCAN 
naloxone hydrochloride nasal spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69547-627
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69547-627-022 in 1 CARTON08/28/2023
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
NDANDA20841108/28/2023
Labeler - Emergent Devices Inc. (079673287)

Revised: 8/2023
Document Id: eca68b75-c15c-4ee0-a352-a4ec66e57424
Set id: a0ebc83d-2892-40de-bc0a-775ce90b30db
Version: 1
Effective Time: 20230808
 
Emergent Devices Inc.