SPL v1
SPL
SPL Set ID 19b0603b-241f-f439-e063-6294a90ae85f
Route
NASAL
Published
Effective Date 2024-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naloxone (4 mg)
Inactive Ingredients
Water Benzalkonium Chloride Edetate Disodium Hydrochloric Acid Sodium Chloride

Identifiers & Packaging

Marketing Status
ANDA Active Since 2023-07-30

Description

Naloxone hydrochloride 4 mg


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.

Indications and Usage

• to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin

• this medicine can save a life

Dosage and Administration

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 911immediately after giving the 1st dose

Step 4: WATCH & GIVE

• WAIT2-3 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

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 55105-1

Emergency treatment of opioid overdose

Directions

Questions?

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

Ndc 51662 1659 1

Ndc 51662 1659 2

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


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

Indications and Usage (34067-9)

• to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin

• this medicine can save a life

Dosage and Administration (34068-7)

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 911immediately after giving the 1st dose

Step 4: WATCH & GIVE

• WAIT2-3 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

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 55105-1 (55105-1)

Emergency treatment of opioid overdose

Directions (DIRECTIONS)

Questions? (QUESTIONS?)

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

Ndc 51662 1659 1 (NDC 51662-1659-1)

Ndc 51662 1659 2 (NDC 51662-1659-2)

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

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

Naloxone hydrochloride 4 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)