NALOXONE HYDROCHLORIDE- naloxone hydrochloride spray 
A-S Medication Solutions

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Naloxone HCl Nasal Spray Drug Facts

Active Ingredient (in each spray)

Naloxone hydrochloride 4 mg

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

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

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

Step 3: CALL

CALL 911immediately after giving the 1st dose

Step 4

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

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

naloxone hydrochloride

Label Image
NALOXONE HYDROCHLORIDE 
naloxone hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-6963(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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-6963-02 in 1 CARTON12/20/2023
1.1 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 - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-6963)

Revised: 12/2023
Document Id: 7a0088db-1e25-49db-9a22-c99cd6adfd8f
Set id: 46f27d04-d4d2-4ef1-9cc5-4d58f4056f06
Version: 2
Effective Time: 20231227
 
A-S Medication Solutions