NALOXONE HYDROCHLORIDE spray

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
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

	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

INGREDIENTS AND APPEARANCE

NALOXONE HYDROCHLORIDE
naloxone hydrochloride spray

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE HYDROCHLORIDE	4 mg in 0.1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 80425-0409-1	2 in 1 CARTON	06/27/2024
1		0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211951	06/27/2024

Labeler - Advanced Rx of Tennessee, LLC (117023142)

Name	Address	ID/FEI	Business Operations
Establishment
Advanced Rx of Tennessee, LLC		117023142	repack(80425-0409)

NALOXONE HYDROCHLORIDE by