NARCAN- naloxone hydrochloride nasal spray

NARCAN by

Drug Labeling and Warnings

NARCAN by is a Otc medication manufactured, distributed, or labeled by Emergent Devices Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

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

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

INGREDIENTS AND APPEARANCE

NARCAN 
naloxone hydrochloride nasal spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69547-627
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE HYDROCHLORIDE	4 mg  in 0.1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69547-627-02	2 in 1 CARTON	08/28/2023
1		0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA208411	08/28/2023

Labeler - Emergent Devices Inc. (079673287)