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Rextovy (Naloxone hydrochloride): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
4 mg/0.25 mL
Other brand names:
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Rextovy

Instructions for Use

REXTOVY (rex toe' vee)

(Naloxone Hydrochloride)

Nasal Spray

You and your family members or caregivers should read the Instructions for Use that comes with REXTOVY™ Nasal Spray before using it. Talk to your healthcare provider if you and your family members or caregivers have any questions about the use of REXTOVY™ Nasal Spray.

Use REXTOVY™ Nasal Spray for known or suspected opioid overdose in adults and children.

Important: For use in the nose only.

  • Do not remove or test the REXTOVY™ Nasal Spray until ready to use.
  • Each REXTOVY™ Nasal Spray has 1 dose and cannot be reused.
  • You do not need to prime REXTOVY™ Nasal Spray.

How to use REXTOVY™ Nasal Spray:

How should I store REXTOVY™ Nasal Spray?

  • Store at room temperature between 68°F to 77°F (20°C to 25°C). REXTOVY™ Nasal Spray may be stored for short periods between 39°F to 104°F (4°C to 40°C).
  • Do not freeze. Do not expose to temperatures below 39°F (4°C) or above 104°F (40°C).
  • Keep REXTOVY™ Nasal Spray in its box until ready to use. Protect from light.
  • Replace REXTOVY™ Nasal Spray before the expiration date on the box.

Keep REXTOVY™ Nasal Spray and all medicines out of the reach of children.

Distributed by International Medication Systems, Limited, So. El Monte, CA 91733, U.S.A.

For more information, go to www.amphastar.com or call 1-800-423-4136.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: 06/2023

7036690F/6-23

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 208969 · View the label on DailyMed

Revision date stated in the text: June 2023

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Rextovy

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Opioid Antagonist
Active ingredient Naloxone hydrochloride 4 mg/0.25 mL
Dosage form Spray
Route Nasal
Marketing status not in the current FDA NDC Directory
Company (applicant) AMPHASTAR PHARMS INC
FDA approval NDA 208969New Drug Application (NDA) Approved March 7, 2023
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
4 mg/0.25 mL – 0.25 ml in 1 container / 2 in 1 container NDC 76329-3669-2

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.