NARCAN- naloxone hydrochloride nasal spray

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 medicationsor street drugs such as heroin
- this medicine can save a life
Warning
- When using this productsome people may experience symptoms when they wake up, such as, shaking, sweating, nausea, or feeling angry. This is to be expected.
KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Directions

NARCAN ®
Naloxone HCl Nasal Spray 4 mg

Emergency Treatment of Opioid Overdose

Important:

	Step 1: CHECK if you suspect an overdose: CHECKfor 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
	Step 2: Give 1st dose in the nose HOLDthe nasal spray device with your thumb on the bottom of the plunger INSERTthe nozzle into either NOSTRIL PRESSthe plunger firmly to give the 1st dose 1 nasal spray device contains 1 dose
	Step 3: CALL 911 CALL 911immediately after giving the l stdose
	Step 4: WATCH & GIVE WAIT2-3 minutes after the l stdose 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 GIVEdoses every 2-3 minutes until the person wakes up it is safe to keep giving doses
	Step 5: STAY STAYuntil ambulance arrives: even if the person wakes up GIVEanother 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.

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

INGREDIENTS AND APPEARANCE

NARCAN
naloxone hydrochloride nasal spray

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 85766-076-02	2 in 1 CARTON	10/10/2025
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 - Sportpharm LLC (125298538)

Mark Image Registration \| Serial	Company Trademark Application Date
NARCAN 98559421 not registered Live/Pending	Emergent Operations Ireland Limited 2024-05-20
NARCAN 88863752 not registered Live/Pending	Adapt Pharma Operations Limited 2020-04-08
NARCAN 88863747 not registered Live/Pending	Adapt Pharma Operations Limited 2020-04-08
NARCAN 87130416 5160883 Live/Registered	Adapt Pharma Operations Limited 2016-08-08
NARCAN 86364205 not registered Dead/Abandoned	Endo Pharmaceuticals Inc. 2014-08-12
NARCAN 72225014 0808366 Live/Registered	ENDO LABORATORIES INC. 1965-08-05

NARCAN by