NARCAN NALOXONE HCL spray

Narcan Naloxone HCL by

Drug Labeling and Warnings

Narcan Naloxone HCL by is a Otc medication manufactured, distributed, or labeled by HF Acquisition Co LLC, DBA HealthFirst. 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

WARNINGS

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

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 INGREDIENT

benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water

QUESTIONS

Call 1-844-4NARCAN (1-844-462-7226) or go to WWW.NARCAN.COM

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PRINCIPAL DISPLAY PANEL- CARTON LABEL

PRINCIPAL DISPLAY PANEL_ NDC:

51662-1642-1

PRINCIPAL DISPLAY PANEL- NDC:

51662-1642-2

INGREDIENTS AND APPEARANCE

NARCAN NALOXONE HCL 
narcan naloxone hcl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51662-1642(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
HYDROCHLORIC ACID (UNII: QTT17582CB)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51662-1642-2	2 in 1 CARTON	08/28/2023
1	NDC: 51662-1642-1	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 - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Establishment
Name	Address	ID/FEI	Business Operations
HF Acquisition Co LLC, DBA HealthFirst		045657305	relabel(51662-1642)