Naloxone Hcl Nasal Spray Drug Facts

SPL v2

SPL

SPL Set ID 46f27d04-d4d2-4ef1-9cc5-4d58f4056f06

Route

NASAL

Published

Effective Date 2023-12-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2023-07-30

Description

Naloxone hydrochloride 4 mg

Purpose

Emergency treatment of opioid overdose

How Supplied

Product: 50090-6963 NDC: 50090-6963-0 .1 mL in a VIAL, SINGLE-DOSE / 2 in a CARTON

Medication Information

Purpose

Emergency treatment of opioid overdose

How Supplied

Product: 50090-6963

NDC: 50090-6963-0 .1 mL in a VIAL, SINGLE-DOSE / 2 in a CARTON

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

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 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

Questions?

call 1-866-634-9120 or go to www.padagis.com

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

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

Naloxone Hydrochloride

Keep Out of Reach of Children

Keep this and all medications out of the reach of children.

Active Ingredient (in Each Spray)

Naloxone hydrochloride 4 mg

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

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 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

Questions?

call 1-866-634-9120 or go to www.padagis.com

How Supplied (HOW SUPPLIED)

Product: 50090-6963

NDC: 50090-6963-0 .1 mL in a VIAL, SINGLE-DOSE / 2 in a CARTON

Other Information (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

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

Naloxone Hydrochloride (naloxone hydrochloride)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep this and all medications out of the reach of children.

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

Naloxone hydrochloride 4 mg

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", "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 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", "Questions?": "call 1-866-634-9120 or go to www.padagis.com", "HOW SUPPLIED": "Product: 50090-6963 NDC: 50090-6963-0 .1 mL in a VIAL, SINGLE-DOSE / 2 in a CARTON", "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": "benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water", "KEEP OUT OF REACH OF CHILDREN": "Keep this and all medications out of the reach of children.", "Active Ingredient (in each spray)": "Naloxone hydrochloride 4 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:40.596467 · Updated: 2026-03-14T23:02:21.986500