Naloxone HCl Nasal Spray Drug Facts

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-866-634-9120

Websitewww.padagis.comwww.padagis.com

Label contents#

Full prescribing information#

Active Ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Naloxone hydrochloride 4 mg

Purpose

OTC - PURPOSE SECTION

Emergency treatment of opioid overdose

Uses

INDICATIONS & USAGE SECTION

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

• this medicine can save a life

Directions

DOSAGE & ADMINISTRATION SECTION

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

holding nasal spray device

Step 1	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	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	Step 3: CALL • CALL 911 immediately after giving the 1st dose
Step 4	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	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

Warning

WARNINGS SECTION

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

Other information

SPL UNCLASSIFIED SECTION

•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

INACTIVE INGREDIENT SECTION

benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water

Questions?

SPL UNCLASSIFIED SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68001-645-45

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

Rev 01/2025

01

NDC 68001-645-45

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

Rev 08/2025

08

Product Linked Resources#

DailyMed Product Concepts#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

• NALOXONE HYDROCHLORIDE
• BENZALKONIUM CHLORIDE
• EDETATE DISODIUM
• SODIUM CHLORIDE
• HYDROCHLORIC ACID
• WATER
• NALOXONE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

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Observed Orange Book normalized TE history#

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