RIVIVE- naloxone hydrochloride spray 
Harm Reduction Therapeutics, Inc.

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RiVive™
Naloxone HCl Nasal Spray 3 mg
Emergency Treatment of Opioid Overdose

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

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

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

Step 3: CALL 911

Get medical help immediately after giving the first dose
Call 911 now
Step 4

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

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

image-01
Label

RIVIVE 
naloxone hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82954-0100
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N) NALOXONE HYDROCHLORIDE3 mg  in 0.1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82954-0100-12 in 1 CARTON01/02/2024
10.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21772201/02/2024
Labeler - Harm Reduction Therapeutics, Inc. (107812954)

Revised: 1/2024
Document Id: 1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d
Set id: 1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d
Version: 1
Effective Time: 20240110
 
Harm Reduction Therapeutics, Inc.