Rivive Spray
FDA Label NDC 82954-0100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harm Reduction Therapeutics, Inc. for the product Rivive (NDC 82954-0100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each spray), purpose, uses, directions, warning, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 (Image 01)

Step 1 (Image 01)

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 (Image 02)

Step 2 (Image 02)

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 (Image 03)

Step 3 (Image 03)

Step 3: CALL 911

  • Get medical help immediately after giving the first dose
  • Call 911 now
Step 4 (Image 04)

Step 4 (Image 04)

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 (Image 05)

Step 5 (Image 05)

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 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

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