Active Ingredient (In Each Spray)
Naloxone hydrochloride 4 mg
Naloxone Hydrochloride Spray
FDA Label NDC 51662-1659
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hf Acquisition Co Llc, Dba Healthfirst for the product Naloxone Hydrochloride (NDC 51662-1659). 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), otc - purpose, uses, directions, warnings, other information, inactive ingredient, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Warnings
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 Ingredient
benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water
Questions?
call 1-866-634-9120 or go to www.padagis.com
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Dosage & Administration
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 911immediately after giving the 1st dose
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: 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
Indications & Usage
• to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin
• this medicine can save a life
Ndc 51662-1659-2
* Please review the disclaimer below.
