Rivive®

Rivive®
SPL v2
SPL
SPL Set ID 1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d
Route
NASAL
Published
Effective Date 2026-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naloxone (3 mg)
Inactive Ingredients
Hydrochloric Acid Water Sodium Chloride Sodium Hydroxide Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
NDA Active Since 2024-01-02
Description

Naloxone hydrochloride 3 mg

Purpose

Emergency treatment of opioid overdose

Medication Information

Purpose

Emergency treatment of opioid overdose

Description

Naloxone hydrochloride 3 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
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.

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
Questions?

for more information call toll-free (888)-412-7454 or go to www.RiVive.com

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

Active Ingredient (in Each Spray)

Naloxone hydrochloride 3 mg

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

Structured Label Content

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

Emergency treatment of opioid overdose

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.

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
Questions?

for more information call toll-free (888)-412-7454 or go to www.RiVive.com

Other Information (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 (Inactive ingredients)

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

Active Ingredient (in Each Spray) (Active ingredient (in each spray))

Naloxone hydrochloride 3 mg

Package/label Principal Display Panel (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:13.702024 · Updated: 2026-03-14T23:12:24.385926