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  5. Label Information: Rivive

FDA Label for Rivive

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SPRAY)
    2. PURPOSE
    3. USES
    4. DIRECTIONS
    5. WARNING
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. QUESTIONS?
    9. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rivive Product Label

The following document was submitted to the FDA by the labeler of this product Harm Reduction Therapeutics, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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



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 2Hold 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 naloxoneGet medical help immediately after giving the first dose
  • Call 911 nowWAIT 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

    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
    Step 1 - image 01

    Step 1 - image 01

    Step 1: CHECK if you suspect an overdose

    ••••

    Step 2: GIVE 1st dose in the nose

    •••

    Step 3: CALL 911

    ••

    Step 4: WATCH & GIVE

    •••

    Step 5: STAY

    •••

    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 20°C to 25°C (68°F to 77°F)
    • •do not refrigerate
    • •avoid excessive heat above 40°C (104°F)
    • •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 - image 06

    image-01 - image 06


    Label


    * Please review the disclaimer below.