NARCAN® Naloxone HCl Nasal Spray 4 mg Drug Facts

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-844-462-7226

Websitewww.narcan.comwww.narcan.com

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Naloxone Hydrochloride 4 mg

Purpose

OTC - PURPOSE SECTION

Emergency treatment of opioid overdose

Uses

INDICATIONS & USAGE SECTION

• to “revive” someone during an overdose from many prescription pain medicationsor street drugs such as heroin
• this medicine can save a life

Warning

WARNINGS SECTION

• 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Directions

DOSAGE & ADMINISTRATION SECTION

NARCAN ^®
Naloxone HCl Nasal Spray 4 mg

Emergency Treatment of Opioid Overdose Important: For use in the nose only Do not test nasal spray device before use 1 nasal spray device contains 1 dose of medicine Each device sprays 1 time only

Naloxone HCl Nasal Spray 4 mg

1. Check	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
2. Give	Step 2: Give 1st dose 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 1st dose 1 nasal spray device contains 1 dose
3. Call	Step 3: CALL 911 CALL 911immediately after giving the l stdose
4. Watch/Give	Step 4: WATCH & GIVE WAIT2-3 minutes after the l 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
5. Stay	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

For opioid emergencies, call 911.For questions on NARCAN, call 1-844-4NARCAN (1-844-462-7226) or go to www.narcan.com.

©2023 Emergent Devices Inc. EMERGENT® and NARCAN® are registered trademarks of Emergent BioSolutions Inc, or its subsidiaries.

Other Information

• store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F)
• 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 INGREDIENT SECTION

benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water

Questions?

OTC - QUESTIONS SECTION

Call 1-844-4NARCAN (1-844-462-7226) or go to www.narcan.com

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1

DailyMed RxNorm Mappings#

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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

• NARCAN
• naloxone hydrochloride nasal
• BENZALKONIUM CHLORIDE
• EDETATE DISODIUM
• SODIUM CHLORIDE
• WATER
• HYDROCHLORIC ACID
• NALOXONE HYDROCHLORIDE
• NALOXONE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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Source XML

Older Hydrated Versions#

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Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Observed Orange Book normalized TE history#

Observed Orange Book patent history#

Patent history page 1 of 5 · 178 observed states.

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.