Active Ingredient (In Each Spray)
Naloxone hydrochloride 4 mg
Naloxone Hydrochloride Spray
FDA Label NDC 50090-6963
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Naloxone Hydrochloride (NDC 50090-6963). 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), keep out of reach of children, purpose, uses, 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
Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children.
Purpose
Emergency treatment of opioid overdose
Uses
• to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin
• this medicine can save a life
Directions
 Step 1 (Image 01) | 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 (Image 02) | 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 (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 GIVE doses every 2-3 minutes until the person wakes up • it is safe to keep giving doses |
 Step 5 (Image 05) | 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
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.
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
How Supplied
Product: 50090-6963
NDC: 50090-6963-0 .1 mL in a VIAL, SINGLE-DOSE / 2 in a CARTON
* Please review the disclaimer below.
