NALOXONE HYDROCHLORIDE spray

NALOXONE HYDROCHLORIDE by

Drug Labeling and Warnings

NALOXONE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by HF Acquisition Co LLC, DBA HealthFirst. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (IN EACH SPRAY)

Naloxone hydrochloride 4 mg

PURPOSE

Emergency treatment of opioid overdose

USES

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

this medicine can save a life

DIRECTIONS

WARNINGS

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.

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 INGREDIENT

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

QUESTIONS?

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DOSAGE & 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

INDICATIONS & USAGE

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

this medicine can save a life

NDC:

51662-1659-1

NDC:

51662-1659-2

INGREDIENTS AND APPEARANCE

NALOXONE HYDROCHLORIDE 
naloxone hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51662-1659(NDC:45802-578)
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE HYDROCHLORIDE	4 mg  in 0.1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51662-1659-2	2 in 1 CARTON	07/30/2023
1	NDC: 51662-1659-1	0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211951	07/30/2023

Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Establishment
Name	Address	ID/FEI	Business Operations
HF Acquisition Co LLC, DBA HealthFirst		045657305	relabel(51662-1659)