Naloxone Hcl Nasal Spray Drug Facts

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

Medication Information

Purpose

Emergency treatment of opioid overdose

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

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

	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.padagisnaloxone.com.

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 45802-578-84

Compare to NARCAN^® active ingredient

Padagis

Naloxone

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 (0.1mL) EACH

FOR USE IN 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

SAFE TO USE EVEN IF OPIOIDS ARE NOT PRESENT

Distributed by Padagis^®

Allegan, MI 49010

www.padagisnaloxone.com

64QJ8 RT C4

Product of USA

64Q00 RT QS5

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

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

	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.padagisnaloxone.com.

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 45802-578-84

Compare to NARCAN^® active ingredient

Padagis

Naloxone

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 (0.1mL) EACH

FOR USE IN 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

SAFE TO USE EVEN IF OPIOIDS ARE NOT PRESENT

Distributed by Padagis^®

Allegan, MI 49010

www.padagisnaloxone.com

64QJ8 RT C4

Product of USA

64Q00 RT QS5

Advanced Ingredient Data

[{"name": "NALOXONE", "unii": "36B82AMQ7N", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "0.1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"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": ""}]

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", "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 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.padagisnaloxone.com.", "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 45802-578-84 Compare to NARCAN ® active ingredient Padagis Naloxone 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 (0.1mL) EACH FOR USE IN 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 SAFE TO USE EVEN IF OPIOIDS ARE NOT PRESENT Distributed by Padagis ® Allegan, MI 49010 www.padagisnaloxone.com 64QJ8 RT C4 Product of USA 64Q00 RT QS5"}

Naloxone Hcl Nasal Spray Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information