Narcan® Naloxone Hcl Nasal Spray 4 Mg Drug Facts

SPL v1

SPL

SPL Set ID 3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92

Route

NASAL

Published

Effective Date 2025-10-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Naloxone (4 mg)

Inactive Ingredients

Benzalkonium Chloride Edetate Disodium Sodium Chloride Water Hydrochloric Acid

Identifiers & Packaging

Marketing Status

NDA Active Since 2023-08-28

Description

Naloxone Hydrochloride 4 mg

Purpose

Emergency treatment of opioid overdose

Medication Information

Purpose

Emergency treatment of opioid overdose

Description

Naloxone Hydrochloride 4 mg

Uses

to “revive” someone during an overdose from many prescription pain medicationsor street drugs such as heroin
this medicine can save a life

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

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.

Directions

NARCAN ^®

Naloxone HCl Nasal Spray 4 mg

Emergency Treatment of Opioid Overdose

Important:

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

	Step 1: CHECK if you suspect an overdose: CHECK for 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 HOLD the nasal spray device with your thumb on the bottom of the plunger INSERT the nozzle into either NOSTRIL PRESS the plunger firmly to give the 1st dose 1 nasal spray device contains 1 dose
	Step 3: CALL 911 CALL 911 immediately after giving the l ^stdose
	Step 4: WATCH & GIVE WAIT 2-3 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 GIVE doses every 2-3 minutes until the person wakes up it is safe to keep giving doses
	Step 5: STAY STAY until ambulance arrives: even if the person wakes up GIVE another 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.

Questions?

Call 1-844-4NARCAN (1-844-462-7226) or go to www.narcan.com

Inactive Ingredients

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

Active Ingredient (in Each Spray)

Naloxone Hydrochloride 4 mg

Package/label Principal Display Panel

Structured Label Content

Uses

to “revive” someone during an overdose from many prescription pain medicationsor street drugs such as heroin
this medicine can save a life

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Purpose

Emergency treatment of opioid overdose

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.

Directions

NARCAN ^®

Naloxone HCl Nasal Spray 4 mg

Emergency Treatment of Opioid Overdose

Important:

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

	Step 1: CHECK if you suspect an overdose: CHECK for 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 HOLD the nasal spray device with your thumb on the bottom of the plunger INSERT the nozzle into either NOSTRIL PRESS the plunger firmly to give the 1st dose 1 nasal spray device contains 1 dose
	Step 3: CALL 911 CALL 911 immediately after giving the l ^stdose
	Step 4: WATCH & GIVE WAIT 2-3 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 GIVE doses every 2-3 minutes until the person wakes up it is safe to keep giving doses
	Step 5: STAY STAY until ambulance arrives: even if the person wakes up GIVE another 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.

Questions?

Call 1-844-4NARCAN (1-844-462-7226) or go to www.narcan.com

Inactive Ingredients

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

Active Ingredient (in Each Spray) (Active ingredient (in each spray))

Naloxone Hydrochloride 4 mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

[{"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NALOXONE", "unii": "36B82AMQ7N", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "0.1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life", "50565-1": "KEEP OUT OF REACH OF CHILDREN", "Purpose": "Emergency treatment of opioid overdose", "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 Emergency Treatment of Opioid Overdose Important: 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 Step 1: CHECK if you suspect an overdose: CHECK for 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 HOLD the nasal spray device with your thumb on the bottom of the plunger INSERT the nozzle into either NOSTRIL PRESS the plunger firmly to give the 1st dose 1 nasal spray device contains 1 dose Step 3: CALL 911 CALL 911 immediately after giving the l st dose Step 4: WATCH & GIVE WAIT 2-3 minutes after the l st dose 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 GIVE doses every 2-3 minutes until the person wakes up it is safe to keep giving doses Step 5: STAY STAY until ambulance arrives: even if the person wakes up GIVE another 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 . ©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.", "Questions?": "Call 1-844-4NARCAN (1-844-462-7226) or go to www.narcan.com", "Inactive Ingredients": "benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water", "Active ingredient (in each spray)": "Naloxone Hydrochloride 4 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:41.991038 · Updated: 2026-03-14T23:13:02.501548