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 medicationsor street drugs such as heroin
- this medicine can save a life

Directions

	Step 1: CHECK if you suspect an overdose: CHECKfor 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 1 stdose in the nose HOLDthe nasal spray device with your thumb on the bottom of the plunger INSERTthe nozzle into either NOSTRIL PRESSthe plunger firmly to give the 1 stdose 1 nasal spray device contains 1 dose
	Step 3: CALL CALL 911immediately after giving the 1 stdose
	Step 4: WATCH & GIVE WAIT2-3 minutes after the 1 stdose 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 GIVEdoses every 2-3 minutes until the person wakes up it is safe to keep giving doses
	Step 5: STAY STAYuntil ambulance arrives: even if the person wakes up GIVEanother dose if the person becomes very sleepy again You may need to give all the doses in the pack

Warning
- When using this productsome 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 ®

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501
KEEP OUT OF REACH OF CHILDREN
Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

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: 76420-867-02	2 in 1 CARTON	10/29/2024
1		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 - Asclemed USA, Inc. (059888437)

Name	Address	ID/FEI	Business Operations
Establishment
ASCLEMED USA INC. DBA ENOVACHEM		059888437	relabel(76420-867)

Naloxone Hydrochloride by