Active Ingredient (In Each Spray)
Naloxone hydrochloride 4 mg
Naloxone Hydrochloride Spray
FDA Label NDC 80425-0409
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Of Tennessee, Llc for the product Naloxone Hydrochloride (NDC 80425-0409). 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, otc - keep out of reach of children, directions, warning, other information, inactive ingredients, 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
 Step 1 (Image 01) | 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 (Image 02) | 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 (Image 03) | Step 3: CALL • CALL 911immediately after giving the 1st dose |
 Step 4 (Image 04) | 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 (Image 05) | 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 |
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: 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
* Please review the disclaimer below.
