Naloxone Hcl Nasal Spray

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 2024-06-27

Medication Information

Purpose

Emergency treatment of opioid overdose

Description

Naloxone hydrochloride 4 mg

Uses

•to “revive” someone during an overdose from many prescription pain medicationsor street drugs such as heroin

•this medicine can save a life

Section 50565-1

Keep out of reach of children.

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

	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

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

Package/label Principal Display Panel

NDC: 80425-0409-01

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

For use in nose only

2 Single-Dose Nasal Spray Devices

0.003 fl oz (0.1mL) each

Structured Label Content

Uses

•to “revive” someone during an overdose from many prescription pain medicationsor street drugs such as heroin

•this medicine can save a life

Section 50565-1 (50565-1)

Keep out of reach of children.

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

	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

Questions?

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

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC: 80425-0409-01

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

For use in nose only

2 Single-Dose Nasal Spray Devices

0.003 fl oz (0.1mL) each

Advanced Ingredient Data

[{"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NALOXONE", "unii": "36B82AMQ7N", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "0.1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "• to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin • this medicine can save a life", "50565-1": "Keep out of reach of children.", "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": "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", "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", "Package/Label Principal Display Panel": "NDC: 80425-0409-01 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 For use in nose only 2 Single-Dose Nasal Spray Devices 0.003 fl oz (0.1mL) each"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information