ACTIVE INGREDIENT (IN EACH SPRAY)

Naloxone Hydrochloride 4 mg

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

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

Directions

For opioid emergencies, call 911. For questions on NARCAN, call 1-844-4NARCAN (1-844-462-7226) or go to WWW.NARCAN.COM.

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.

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

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

keep out of reach of children

PRINCIPAL DISPLAY PANEL- CARTON LABEL

CARTON LABEL

PRINCIPAL DISPLAY PANEL_ NDC 51662-1642-1

pack

RFID Label

PRINCIPAL DISPLAY PANEL- NDC 51662-1642-2

pack

RFID Label

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA208411	08/28/2023

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

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

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