NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE BLUEPOINT LABORATORIES FDA Approved Uses • to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin • this medicine can save a life
FunFoxMeds box
Route
NASAL
Applications
ANDA211951
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient (in each spray) Naloxone hydrochloride 4 mg
Inactive Ingredients
Inactive Ingredients benzalkonium chloride edetate disodium hydrochloric acid sodium chloride water
Strengths
4 mg
Quantities
1 ml
Treats Conditions
Uses To Revive Someone During An Overdose From Many Prescription Pain Medications Or Street Drugs Such As Heroin This Medicine Can Save A Life

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0368001645454
UNII
F850569PQR
Packaging

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 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 01 08

Package Descriptions
  • 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 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 01 08

Overview

Uses • to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin • this medicine can save a life

Indications & Usage

Uses • to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin • this medicine can save a life

Dosage & Administration

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 holding nasal spray device Step 1 Step 2 Step 3 Step 4 Step 5

Warnings & Precautions
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
Purpose

Purpose Emergency treatment of opioid overdose


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