RIVIVE- naloxone hydrochloride spray

Active ingredient (in each spray)

Naloxone hydrochloride 3 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

	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 nasal spray device with thumb on plunger and a finger on each side of the nozzle Insert nozzle into one nostril and press plunger firmly Each nasal spray device contains only one dose of naloxone
	Step 3: CALL 911 Get medical help immediately after giving the first dose Call 911 now
	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: Give a second dose of medicine using a new nasal spray device It is safe to keep giving doses every 2-3 minutes until the person wakes up
	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

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.
Other information
- store at 20ºC to 25ºC (68ºF to 77ºF)
- do not refrigerate
- avoid excessive heat above 40ºC (104ºF)
- do not use if sealed blister package is torn or opened
Inactive ingredients

hydrochloric acid, purified water, sodium chloride, sodium hydroxide, trisodium citrate dihydrate
Questions?

for more information call toll-free (888)-412-7454 or go to www.RiVive.com
Package/Label Principal Display Panel

RiVive®
Naloxone HCl Nasal Spray 3 mg

Emergency Treatment
of Opioid Overdose

FOR USE IN
THE NOSE ONLY
NOZZLE
PLUNGER
EASY
TO USE

2-Single-Dose
Nasal Spray Devices
0.003 fl oz (0.1 mL) each

HARM REDUCTION
THERAPEUTICS
Distributed by Harm Reduction Therapeutics, Inc.
Bethesda, MD 20814

Label

INGREDIENTS AND APPEARANCE

RIVIVE
naloxone hydrochloride spray

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)	NALOXONE HYDROCHLORIDE	3 mg in 0.1 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 82954-0100-1	2 in 1 CARTON	01/02/2024
1		0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA217722	01/02/2024

Labeler - Harm Reduction Therapeutics, Inc. (107812954)

Mark Image Registration \| Serial	Company Trademark Application Date
RIVIVE 98565855 not registered Live/Pending	Haws Corporation 2024-05-23
RIVIVE 97323739 not registered Live/Pending	Harm Reduction Therapeutics, Inc. 2022-03-22
RIVIVE 88113597 not registered Live/Pending	Harm Reduction Therapeutics, Inc. 2018-09-12

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