Narcan Spray
FDA Label NDC 85766-076

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sportpharm Llc for the product Narcan (NDC 85766-076). 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, 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 medicationsor street drugs such as heroin
  • this medicine can save a life

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
Naloxone HCl Nasal Spray 4 mg (Image 01)

Naloxone HCl Nasal Spray 4 mg (Image 01)

  • 1. Check (Image 02)

    1. Check (Image 02)

Step 1: CHECK if you suspect an overdose:

  • CHECKfor 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
  • 2. Give (Image 03)

    2. Give (Image 03)

Step 2: Give 1st dose in the nose

  • HOLDthe nasal spray device with your thumb on the bottom of the plunger
  • INSERTthe nozzle into either NOSTRIL
  • PRESSthe plunger firmly to give the 1st dose
  • 1 nasal spray device contains 1 dose
  • 3. Call (Image 04)

    3. Call (Image 04)

Step 3: CALL 911

  • CALL 911immediately after giving the l stdose
  • 4. Watch/give (Image 05)

    4. Watch/give (Image 05)

Step 4: WATCH & GIVE

  • WAIT2-3 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 GIVEdoses every 2-3 minutes until the person wakes up
    • it is safe to keep giving doses
  • 5. Stay (Image 06)

    5. Stay (Image 06)

Step 5: STAY

  • STAYuntil ambulance arrives: even if the person wakes up
  • GIVEanother 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

1 (Label)

1 (Label)

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