NALOXONE HYDROCHLORIDE spray, metered

Active ingredient (in each spray)

Naloxone hydrochloride 4 mg
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

	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 911 immediately after giving the 1st dose
	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: 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 below 77°F (25°C).
- 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, 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
SPL UNCLASSIFIED SECTION

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
KEEP OUT OF REACH OF CHILDREN
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

NALOXONE HYDROCHLORIDE
naloxone hydrochloride spray, metered

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE HYDROCHLORIDE	4 mg in 0.1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 0480-3478-68	2 in 1 CARTON	09/23/2024
1	NDC: 0480-3478-19	1 in 1 BLISTER PACK
1		0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209522	09/23/2024

Labeler - Teva Pharmaceuticals, Inc. (022629579)

Naloxone Hydrochloride by