NALOXONE HYDROCHLORIDE- naloxone hydrochloride spray 
HF Acquisition Co LLC, DBA HealthFirst

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ACTIVE INGREDIENT (IN EACH SPRAY)

Naloxone hydrochloride 4 mg

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

Directions

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

benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water

QUESTIONS?

call 1-866-634-9120 or go to www.padagis.com

KEEP OUT OF REACH OF CHILDREN

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

• to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin

• this medicine can save a life

NDC 51662-1659-1

UNBOXED

NDC 51662-1659-2

CARTON LABEL

RFID Label

NALOXONE HYDROCHLORIDE 
naloxone hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51662-1659(NDC:45802-578)
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N) NALOXONE HYDROCHLORIDE4 mg  in 0.1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51662-1659-22 in 1 CARTON07/30/2023
1NDC:51662-1659-10.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21195107/30/2023
Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
NameAddressID/FEIBusiness Operations
HF Acquisition Co LLC, DBA HealthFirst045657305relabel(51662-1659)

Revised: 5/2024
Document Id: 19b0603b-2420-f439-e063-6294a90ae85f
Set id: 19b0603b-241f-f439-e063-6294a90ae85f
Version: 1
Effective Time: 20240530
 
HF Acquisition Co LLC, DBA HealthFirst