Naloxone HCl Nasal Spray

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

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: 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

Naloxone HCl Nasal Spray #2

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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#

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

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