Active Ingredient (In Each Spray)
Naloxone hydrochloride 4 mg
Naloxone Hydrochloride Spray
FDA Label NDC 68001-645
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bluepoint Laboratories for the product Naloxone Hydrochloride (NDC 68001-645). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each spray), purpose, uses, directions, warning, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Emergency treatment of opioid overdose
Uses
•to “revive” someone during an overdose from many prescription pain medicationsor street drugs such as heroin
•this medicine can save a life
Directions
Emergency Treatment of Opioid Overdose
Important:
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 (Device) |
 Step 1 (Step1) | Step 1: CHECK if you suspect an overdose: • CHECKfor 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 (Step2) | Step 2: GIVE 1st dose in the nose • HOLDthe nasal spray device with your thumb on the bottom of the plunger • INSERTthe nozzle into either NOSTRIL • PRESSthe plunger firmly to give the 1st dose •1 nasal spray device contains 1 dose |
 Step 3 (Step3) | Step 3: CALL • CALL 911immediately after giving the 1st dose |
 Step 4 (Step4) | Step 4: WATCH & GIVE • WAIT2-3 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 GIVEdoses every 2-3 minutes until the person wakes up •it is safe to keep giving doses |
 Step 5 (Step5) | Step 5: STAY • STAYuntil ambulance arrives: even if the person wakes up • GIVEanother 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
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
•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
Questions?
- call 1-866-634-9120 or go to www.padagis.com
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
* Please review the disclaimer below.
