Drug Facts

Composition & Product

Active Ingredients

Naloxone (4 mg)

Inactive Ingredients

Benzalkonium Chloride Edetate Disodium Sodium Chloride Hydrochloric Acid Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2025-01-17

Medication Information

Purpose

Emergency treatment

of opioid overdose

Description

Naloxone hydrochloride 4 mg

Uses

to “revive” someone during an overdose from many prescription

pain medications or street drugs such as heroin
this medicine can save a life

Section 50565-1

*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

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.

Directions

	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 1^stdose 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 1^stdose 1 nasal spray device contains 1 dose
	Step 3: CALL CALL 911 immediately after giving the 1^stdose
	Step 4: WATCH & GIVE WAIT 2-3 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 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

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday.

www.tevausa.com/our-products/tevagenerics

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

Active Ingredient (in Each Spray)

Naloxone hydrochloride 4 mg

Package Label Principal Display Panel

NOT FOR RESALE

FOR NON-RETAIL

DISTRIBUTION

Compare to the active

ingredient in NARCAN^®*

NDC 0591-3871-99

Naloxone Hydrochloride

Nasal Spray

4mg

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

Structured Label Content

Uses

to “revive” someone during an overdose from many prescription

pain medications or street drugs such as heroin
this medicine can save a life

Section 50565-1 (50565-1)

*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

Purpose

Emergency treatment

of opioid overdose

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.

Directions

	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 1^stdose 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 1^stdose 1 nasal spray device contains 1 dose
	Step 3: CALL CALL 911 immediately after giving the 1^stdose
	Step 4: WATCH & GIVE WAIT 2-3 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 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

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday.

www.tevausa.com/our-products/tevagenerics

Other Information (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 (Inactive ingredients)

benzalkonium chloride, edetate disodium, sodium chloride

buffered with sodium hydroxide/hydrochloric acid, water

Active Ingredient (in Each Spray) (Active ingredient (in each spray))

Naloxone hydrochloride 4 mg

Package Label Principal Display Panel (PACKAGE LABEL PRINCIPAL DISPLAY PANEL)

NOT FOR RESALE

FOR NON-RETAIL

DISTRIBUTION

Compare to the active

ingredient in NARCAN^®*

NDC 0591-3871-99

Naloxone Hydrochloride

Nasal Spray

4mg

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

Advanced Ingredient Data

[{"name": "NALOXONE", "unii": "36B82AMQ7N", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "0.1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life", "50565-1": "*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", "Purpose": "Emergency treatment of opioid overdose", "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.", "Directions": "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 1 st 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 1 st dose 1 nasal spray device contains 1 dose Step 3: CALL CALL 911 immediately after giving the 1 st dose Step 4: WATCH & GIVE WAIT 2-3 minutes after the 1 st 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", "Questions?": "1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday. www.tevausa.com/our-products/tevagenerics", "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", "Active ingredient (in each spray)": "Naloxone hydrochloride 4 mg", "PACKAGE LABEL PRINCIPAL DISPLAY PANEL": "NOT FOR RESALE FOR NON-RETAIL DISTRIBUTION Compare to the active ingredient in NARCAN ®* NDC 0591-3871-99 Naloxone Hydrochloride Nasal Spray 4mg 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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information