Label: RIVIVE- naloxone hydrochloride spray

  • NDC Code(s): 82954-0100-1
  • Packager: Harm Reduction Therapeutics, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 10, 2024

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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