narcan® naloxone hcl nasal spray 4 mg drug facts

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

Medication Information

Uses

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

Purpose

Emergency treatment of opioid overdose

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.

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

Description

Naloxone Hydrochloride 4 mg

Questions?

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

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.

Active Ingredient (in Each Spray)

Naloxone Hydrochloride 4 mg

Package/label Principal Display Panel – Carton Label

NARCAN^®

Naloxone HCl Nasal Spray 4 mg

Emergency Treatment of Opioid Overdose

Original

Prescription

Strength

Easy to Use

Can Save a Life

Designed to

Rapidly Reverse

the Effects of a

Life-Threatening

Opioid Emergency

2 Single-Dose Nasal Spray Devices

0.003 fl oz (0.1 mL) each

For use in

nose only

Distributed by Emergent Devices Inc.

Plymouth Meeting, PA 19462 USA

NARCAN^® is a registered trademark of Emergent Operations

Ireland Limited.

NDC 69547-627-02

Package/label Principal Display Panel 4 Mg Vial Package

NDC 69547-627-02

NARCAN^®

Naloxone HCl Nasal Spray 4 mg

Emergency Treatment of Opioid Overdose

•
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
•
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)

Lot XXXXXX EXP YYYY-MMM

Distributed by Emergent Devices Inc.

Plymouth Meeting, PA 19462 USA A1160

Package/label Principal Display Panel – Front and Back Label

NARCAN^®

Naloxone HCl Nasal Spray 4 mg

141357

A1158

FOR USE IN THE NOSE ONLY

NDC 69547-627-02

A1159

Distributed by Emergent Devices, Inc.

Plymouth Meeting, PA 19462, USA

141358

Lot XXXXXX

EXP YYYY-MMM

Structured Label Content

Uses

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

Purpose

Emergency treatment of opioid overdose

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.

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

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.

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

Naloxone Hydrochloride 4 mg

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

NARCAN^®

Naloxone HCl Nasal Spray 4 mg

Emergency Treatment of Opioid Overdose

Original

Prescription

Strength

Easy to Use

Can Save a Life

Designed to

Rapidly Reverse

the Effects of a

Life-Threatening

Opioid Emergency

2 Single-Dose Nasal Spray Devices

0.003 fl oz (0.1 mL) each

For use in

nose only

Distributed by Emergent Devices Inc.

Plymouth Meeting, PA 19462 USA

NARCAN^® is a registered trademark of Emergent Operations

Ireland Limited.

NDC 69547-627-02

Package/label Principal Display Panel 4 Mg Vial Package (Package/Label Principal Display Panel - 4 mg Vial Package)

NDC 69547-627-02

NARCAN^®

Naloxone HCl Nasal Spray 4 mg

Emergency Treatment of Opioid Overdose

•
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
•
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)

Lot XXXXXX EXP YYYY-MMM

Distributed by Emergent Devices Inc.

Plymouth Meeting, PA 19462 USA A1160

Package/label Principal Display Panel – Front and Back Label (Package/Label Principal Display Panel – Front and Back Label)

NARCAN^®

Naloxone HCl Nasal Spray 4 mg

141357

A1158

FOR USE IN THE NOSE ONLY

NDC 69547-627-02

A1159

Distributed by Emergent Devices, Inc.

Plymouth Meeting, PA 19462, USA

141358

Lot XXXXXX

EXP YYYY-MMM

Advanced Ingredient Data

[{"name": "NALOXONE", "unii": "36B82AMQ7N", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "0.1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"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": ""}]

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", "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", "Package/Label Principal Display Panel – Carton Label": "NARCAN ® Naloxone HCl Nasal Spray 4 mg Emergency Treatment of Opioid Overdose Original Prescription Strength Easy to Use Can Save a Life Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency 2 Single-Dose Nasal Spray Devices 0.003 fl oz (0.1 mL) each For use in nose only Distributed by Emergent Devices Inc. Plymouth Meeting, PA 19462 USA ©2023 Emergent Devices Inc. Plymouth Meeting, PA. All rights reserved. NARCAN ® is a registered trademark of Emergent Operations Ireland Limited. NDC 69547-627-02", "Package/Label Principal Display Panel - 4 mg Vial Package": "NDC 69547-627-02 NARCAN ® Naloxone HCl Nasal Spray 4 mg Emergency Treatment of Opioid Overdose • 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 • 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) Lot XXXXXX EXP YYYY-MMM Distributed by Emergent Devices Inc. Plymouth Meeting, PA 19462 USA A1160", "Package/Label Principal Display Panel – Front and Back Label": "NARCAN ® Naloxone HCl Nasal Spray 4 mg 141357 A1158 FOR USE IN THE NOSE ONLY NDC 69547-627-02 A1159 Distributed by Emergent Devices, Inc. Plymouth Meeting, PA 19462, USA 141358 Lot XXXXXX EXP YYYY-MMM"}

narcan® naloxone hcl nasal spray 4 mg drug facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information