Label: NALOXONE HYDROCHLORIDE spray

  • NDC Code(s): 45802-578-00, 45802-578-84
  • Packager: Padagis Israel Pharmaceuticals Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 25, 2024

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  • Active Ingredient (in each spray)
    Naloxone hydrochloride 4 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
    Emergency Treatment of Opioid Overdose - Important: • For use in the nose only - • Do not test nasal spray device before use - • 1 nasal spray device contains 1 dose of medicine - • Each ...
  • 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 room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F) • do not freeze - • avoid excessive heat above 40°C (104°F) • protect from light - • the product is packaged in ...
  • Inactive Ingredients
    benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water
  • Questions?
    call 1-866-634-9120 or go to www.padagis.com
  • Package/Label Principal Display Panel
    NDC 45802-578-84 - Naloxone HCl Nasal Spray 4 mg - Emergency Treatment of Opioid Overdose - Original Prescription Strength - Easy to Use - Can Save a Life - Designed to Rapidly Reverse the Effects of a ...
  • INGREDIENTS AND APPEARANCE
    Product Information