NALOXONE HYDROCHLORIDE- naloxone hydrochloride spray 
Amneal Pharmaceuticals NY LLC

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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

Questions or comments?

1-877-835-5472 (Mon-Fri, 9AM-5PM EST)

DIRECTIONS

Naloxone Hydrochloride Nasal Spray, 4 mg

 

Emergency Treatment of Opioid Overdose

Important:

hand
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

For opioid emergencies, call 911.For questions or more information about Naloxone Hydrochloride Nasal Spray, contact Amneal Pharmaceuticals at 1-877-835-5472.

Rev. 07-2023-04

Principal Display Panel

carton
NALOXONE HYDROCHLORIDE 
naloxone hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69238-2104
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:69238-2104-72 in 1 CARTON04/24/2024
1NDC:69238-2104-10.1 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
ANDAANDA21799204/24/2024
Labeler - Amneal Pharmaceuticals NY LLC (123797875)
Establishment
NameAddressID/FEIBusiness Operations
Amneal Pharmaceuticals, LLC079823130analysis(69238-2104) , label(69238-2104) , manufacture(69238-2104) , pack(69238-2104)

Revised: 4/2024
Document Id: 6c4e802b-21fe-48d0-b969-abf18d8d6ce8
Set id: 8091a73d-9ecd-4578-a57b-5d85a2c5a16a
Version: 8
Effective Time: 20240430
 
Amneal Pharmaceuticals NY LLC