Narcan® Naloxone Hcl Nasal Spray 4 Mg Drug Facts

Narcan® Naloxone Hcl Nasal Spray 4 Mg Drug Facts
SPL v1
SPL
SPL Set ID a0ebc83d-2892-40de-bc0a-775ce90b30db
Route
NASAL
Published
Effective Date 2023-08-08
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 medications or street drugs such as heroin
  • •
    this medicine can save a life
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 lst dose
  •  

Step 4: WATCH & GIVE

  • •
    WAIT 2-3 minutes after the lst 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

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

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 lst dose
  •  

Step 4: WATCH & GIVE

  • •
    WAIT 2-3 minutes after the lst 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) (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

©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 (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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:13.242813 · Updated: 2026-03-14T23:01:17.657881