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

Package/Label Principal Display Panel - 4 mg Vial Package

Package/Label Principal Display Panel – Front and Back Label

Package/Label Principal Display Panel – Carrying Case Label

Package/Label Principal Display Panel – Carrying Case Carton Label

Package/Label Principal Display Panel – 6ct Carton Label

Package/Label Principal Display Panel – 24ct Carton Label

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: 69547-627-05	1 in 1 CARTON	03/15/2026
1		2 in 1 CASE
1		0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 69547-627-02	2 in 1 CARTON	08/28/2023
2		0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 69547-627-06	6 in 1 CARTON	03/15/2026
3		0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4	NDC: 69547-627-24	24 in 1 CARTON	03/15/2026
4		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)