Naloxone Hcl Nasal Spray Drug Facts

Naloxone Hcl Nasal Spray Drug Facts
SPL v100
SPL
SPL Set ID ed549649-dcbd-41f7-a774-876906751c5a
Route
NASAL
Published
Effective Date 2024-10-03
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 Hydrochloric Acid Water

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-07-30

Description

Naloxone hydrochloride 4 mg

Purpose

Emergency treatment of opioid overdose

How Supplied

Naloxone HCl Nasal Spray 4 mg NDC: 72162-2376-2: 2 Single-Dose Vials in a Carton Store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Purpose

Emergency treatment of opioid overdose

How Supplied

Naloxone HCl Nasal Spray 4 mg

NDC: 72162-2376-2: 2 Single-Dose Vials in a Carton

Store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F)

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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

Section 51945-4

Naloxone HCl 4mg Nasal Spray #2

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

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

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

CALL 911 immediately after giving the 1st dose

Step 4: WATCH & GIVE

WAIT 2-3 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 2-3 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 Naloxone HCl Nasal Spray 4 mg, call Padagis® at 1-866-634-9120 or go to www.padagis.com.

64Q00 RT QS2

Questions?
  • call 1-866-634-9120 or go to www.padagis.com
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

Active Ingredient (in Each Spray)

Naloxone hydrochloride 4 mg


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

Section 51945-4 (51945-4)

Naloxone HCl 4mg Nasal Spray #2

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

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

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

CALL 911 immediately after giving the 1st dose

Step 4: WATCH & GIVE

WAIT 2-3 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 2-3 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 Naloxone HCl Nasal Spray 4 mg, call Padagis® at 1-866-634-9120 or go to www.padagis.com.

64Q00 RT QS2

Questions?
  • call 1-866-634-9120 or go to www.padagis.com
How Supplied (HOW SUPPLIED)

Naloxone HCl Nasal Spray 4 mg

NDC: 72162-2376-2: 2 Single-Dose Vials in a Carton

Store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F)

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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

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

Active Ingredient (in Each Spray) (Active Ingredient (in each spray))

Naloxone hydrochloride 4 mg


Advanced Ingredient Data


Raw Label Data

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