Rextovy 4 mg/0.25 mL Nasal Spray, 2 Single-Dose Devices/Pack

Rextovy — 4 mg in 0.25 mL, Spray, 1 × 0.25 mL container

Rextovy (Naloxone Hydrochloride) is a spray for nasal use. REXTOVY Nasal Spray is indicated for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. REXTOVY Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present.

• Active ingredient or product type: NALOXONE HYDROCHLORIDE
• Strength/concentration: 4 mg in 0.25 mL
• Dosage form and route: Spray, Nasal
• Exact package presentation: 1 × 0.25 mL container
• NDC/item number: 76329-3669-2
• Manufacturer: INTERNATIONAL MED SYS (IMS)
• Storage/handling: Store REXTOVY Nasal Spray in the blister and cartons provided. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 4°C to 40°C (39°F to 104°F). Do not freeze.
• Status: Rx only

Important safety information: Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray device with each dose, as necessary, while awaiting emergency medical assistance. ( 5.1 ) Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorp

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.