DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Naloxone (4 mg)

Inactive Ingredients

Hydrochloric Acid Edetate Disodium Sodium Chloride Benzalkonium Chloride Water

Identifiers & Packaging

Marketing Status

NDA Active Since 2023-08-28

Medication Information

Warnings and Precautions

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.

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

keep out of reach of children

Section 51727-6

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

Section 53413-1

Call 1-844-4NARCAN (1-844-462-7226) or go to WWW.NARCAN.COM

Section 55105-1

Emergency treatment of opioid overdose

Directions

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

Active Ingredient (in Each Spray)

Naloxone Hydrochloride 4 mg

Principal Display Panel Carton Label

Principal Display Panel Ndc 51662 1642 2

Principal Display Panel Ndc 51662 1642 1

Structured Label Content

Uses (USES)

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

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

keep out of reach of children

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Call 1-844-4NARCAN (1-844-462-7226) or go to WWW.NARCAN.COM

Section 55105-1 (55105-1)

Emergency treatment of opioid overdose

Directions (DIRECTIONS)

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

Active Ingredient (in Each Spray) (ACTIVE INGREDIENT (IN EACH SPRAY))

Naloxone Hydrochloride 4 mg

Principal Display Panel Carton Label (PRINCIPAL DISPLAY PANEL- CARTON LABEL)

Principal Display Panel Ndc 51662 1642 2 (PRINCIPAL DISPLAY PANEL- NDC 51662-1642-2)

Principal Display Panel Ndc 51662 1642 1 (PRINCIPAL DISPLAY PANEL_ NDC 51662-1642-1)

Advanced Ingredient Data

[{"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "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": "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": "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", "34071-1": "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.", "50565-1": "keep out of reach of children", "51727-6": "benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water", "53413-1": "Call 1-844-4NARCAN (1-844-462-7226) or go to WWW.NARCAN.COM", "55105-1": "Emergency treatment of opioid overdose", "DIRECTIONS": "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.", "ACTIVE INGREDIENT (IN EACH SPRAY)": "Naloxone Hydrochloride 4 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information