NALOXONE HYDROCHLORIDE- naloxone hydrochloride spray 
AvKARE

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Naloxone Hydrochloride Nasal Spray

Active ingredient (in each spray)

Naloxone hydrochloride 4 mg

Purpose

Emergency treatment of opioid overdose

Use(s)

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.

Directions

1 check

Step 1: CHECK if you suspect an overdose

2 give

Step 2: GIVE 1st dose in the nose

3 call

Step 3: CALL 911

step 4

Step 4: WATCH & GIVE

5 stay

Step 5: STAY

Other information

Inactive ingredients

benzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride

DIRECTIONS

Naloxone Hydrochloride Nasal Spray, 4 mg

Emergency Treatment of Opioid Overdose

Important:

hand1 check

Step 1: CHECK if you suspect an overdose

2 give

Step 2: GIVE 1st dose in the nose

3 call

Step 3: CALL 911

step 4

Step 4: WATCH & GIVE

5 stay

Step 5: STAY

For opioid emergencies, call 911.For questions or more information about Naloxone Hydrochloride Nasal Spray, contact

AvKARE at 1-855-361-3993.

Mfg. Rev. 03-2023-01 AV 05/23

Principal Display Panel

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NALOXONE HYDROCHLORIDE 
naloxone hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42291-493
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)  
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Product Characteristics
Colorwhite (clear, colorless to faintly yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42291-493-022 in 1 CARTON05/01/2024
1NDC:42291-493-010.1 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
ANDAANDA21799205/01/2024
Labeler - AvKARE (796560394)

Revised: 5/2024
Document Id: 1766a7fe-030a-8b31-e063-6294a90aa9a8
Set id: 1766a7f1-d301-945f-e063-6294a90ac6f4
Version: 1
Effective Time: 20240501
 
AvKARE