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  5. Label Information: Naloxone Hydrochloride

FDA Label for Naloxone Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SPRAY)
    2. PURPOSE
    3. USES
    4. OTC - KEEP OUT OF REACH OF CHILDREN
    5. DIRECTIONS
    6. WARNING
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS?
    10. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Naloxone Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Advanced Rx Of Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Spray)



Naloxone hydrochloride 4 mg


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



Step 1 - image 01

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: 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: 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 GIVEdoses every 2-3 minutes until the person wakes up

    •it is safe to keep giving doses

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.