NALOXONE HYDROCHLORIDE- naloxone hydrochloride spray, metered 
Teva Pharmaceuticals, Inc.

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Drug Facts

Active ingredient (in each spray)

Naloxone hydrochloride 4 mg

Purpose

Emergency treatment of opioid overdose

Uses

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 911 immediately after giving the 1st dose
 step 4

Step 4: WATCH & GIVE

  • WAIT 2-3 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

Other information

Inactive Ingredients

benzalkonium chloride, edetate disodium, sodium chloride buffered with sodium hydroxide/hydrochloric acid, water

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday.
www.tevausa.com/our-products/tevagenerics

 Safe to Use
Even if Opioids are Not Present

*This product is not affiliated with, manufactured by, or produced by
the makers or owners of NARCAN®

Manufactured For: Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054

Rev. A 1/2024

Package/Label Principal Display Panel – Carton Label

Original Prescription Strength
Easy to Use
Can Save a Life

Compare to the active
ingredient in NARCAN®*

NDC 0480-3478-68

Naloxone Hydrochloride
Nasal Spray
4 mg

Emergency Treatment of
Opioid Overdose

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 (0.1 mL) each

4 mg carton
NALOXONE HYDROCHLORIDE 
naloxone hydrochloride spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0480-3478
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:0480-3478-682 in 1 CARTON09/23/2024
1NDC:0480-3478-191 in 1 BLISTER PACK
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
ANDAANDA20952209/23/2024
Labeler - Teva Pharmaceuticals, Inc. (022629579)

Revised: 1/2024
Document Id: 7545d296-ad3c-4be1-9913-73b4f870e90c
Set id: 3a73ee4b-c2a4-496f-be90-9f78c8046062
Version: 2
Effective Time: 20240101
 
Teva Pharmaceuticals, Inc.