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  5. Label Information: Narcan

FDA Label for Narcan

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SPRAY)
    2. PURPOSE
    3. USES
    4. WARNING
    5. DIRECTIONS
    6. INACTIVE INGREDIENTS
    7. QUESTIONS?
    8. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – CARTON LABEL
    9. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 4 MG VIAL PACKAGE
    10. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – FRONT AND BACK LABEL

Narcan Product Label

The following document was submitted to the FDA by the labeler of this product Emergent Devices Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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

    Emergency Treatment of Opioid Overdose

     

    Important:

    ••••
    Naloxone HCl Nasal Spray 4 mg - image 01

    Naloxone HCl Nasal Spray 4 mg - image 01

    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 2HOLD 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 doseCALL 911 immediately after giving the lst doseWAIT 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 dosesSTAY 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
     

    Step 1: CHECK if you suspect an overdose:

    ••••
     

    Step 2: Give 1st dose in the nose

    ••••
     

    Step 3: CALL 911

    •
     

    Step 4: WATCH & GIVE

    •••••
     

    Step 5: STAY

    •••

    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


    Questions?



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


    Package/Label Principal Display Panel – Carton Label



    Package/Label Principal Display Panel - Carton Label - image 07

    Package/Label Principal Display Panel - Carton Label - image 07

    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 - image 08

    Package/Label Principal Display Panel - 4 mg Vial Package - image 08

    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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