Naloxone Hydrochloride Nasal Spray

Naloxone Hydrochloride Nasal Spray
SPL v2
SPL
SPL Set ID 1766a7f1-d301-945f-e063-6294a90ac6f4
Route
NASAL
Published
Effective Date 2024-04-23
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

Pill Appearance
Color: white
Marketing Status
ANDA Active Since 2024-05-01
Description

Naloxone hydrochloride 4 mg

Purpose

Emergency treatment of opioid overdose

Medication Information

Purpose

Emergency treatment of opioid overdose

Description

Naloxone hydrochloride 4 mg

Use(s)
  • to “revive” someone during an overdose from many  prescription pain medicationsor street drugs such as heroin
  • this medicine can save a life
Directions

Naloxone Hydrochloride 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 1st dose

Step 4: WATCH & GIVE

  • WAIT 2 to 3 minutes after the 1st 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 to 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 or more information about Naloxone Hydrochloride Nasal Spray, contact

AvKARE at 1-855-361-3993.

Mfg. Rev. 03-2023-01 AV 05/23

Directions

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 1st dose

Step 4: WATCH & GIVE

  • WAIT 2 to 3 minutes after the 1st 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 to 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
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
  • this 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, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride

Principal Display Panel

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

Structured Label Content

Use(s)
  • to “revive” someone during an overdose from many  prescription pain medicationsor street drugs such as heroin
  • this medicine can save a life
Purpose

Emergency treatment of opioid overdose

Directions (DIRECTIONS)

Naloxone Hydrochloride 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 1st dose

Step 4: WATCH & GIVE

  • WAIT 2 to 3 minutes after the 1st 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 to 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 or more information about Naloxone Hydrochloride Nasal Spray, contact

AvKARE at 1-855-361-3993.

Mfg. Rev. 03-2023-01 AV 05/23

Directions

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 1st dose

Step 4: WATCH & GIVE

  • WAIT 2 to 3 minutes after the 1st 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 to 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
Other Information (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
  • this 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 (Inactive ingredients)

benzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride

Principal Display Panel

When Using This Product (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:13.692380 · Updated: 2026-03-14T23:12:24.385926