Narcan Spray
FDA Label NDC 69547-627

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Emergent Devices Inc. for the product Narcan (NDC 69547-627). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each spray), purpose, uses, warning, directions, inactive ingredients, questions?, package/label principal display panel – carton label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 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
Naloxone HCl Nasal Spray 4 mg (Image 01)

Naloxone HCl Nasal Spray 4 mg (Image 01)

1. Check (Image 02)

1. Check (Image 02)

2. Give (Image 03)

2. Give (Image 03)

3. Call (Image 04)

3. Call (Image 04)

4. Watch/give (Image 05)

4. Watch/give (Image 05)

5. Stay (Image 06)

5. Stay (Image 06)

 

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.

Inactive Ingredients

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

Package/Label Principal Display Panel – Carton Label

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)

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 (Image 09)

Package/label Principal Display Panel – Front And Back Label (Image 09)

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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