Label: NALOXONE HYDROCHLORIDE spray, metered
- NDC Code(s): 67296-1928-2
- Packager: Redpharm Drug
- This is a repackaged label.
- Source NDC Code(s): 0093-2165
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 7, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use NALOXONE HYDROCHLORIDE NASAL SPRAY safely and effectively. See full prescribing information for NALOXONE HYDROCHLORIDE NASAL ...
-
Table of ContentsTable of Contents
-
1 INDICATIONS AND USAGENaloxone hydrochloride nasal spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Naloxone ...
-
2 DOSAGE AND ADMINISTRATION2.1 Important Administration Instructions - Naloxone hydrochloride nasal spray is for intranasal use only. No additional device assembly is required. Because treatment of suspected opioid ...
-
3 DOSAGE FORMS AND STRENGTHSNaloxone hydrochloride nasal spray is supplied as a single-dose intranasal spray containing 4 mg of naloxone hydrochloride in 0.1 mL.
-
4 CONTRAINDICATIONSNaloxone hydrochloride nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.
-
5 WARNINGS AND PRECAUTIONS5.1 Risk of Recurrent Respiratory and Central Nervous System Depression - The duration of action of most opioids may exceed that of naloxone hydrochloride nasal spray resulting in a return of ...
-
6 ADVERSE REACTIONSThe following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal - [see Warnings and Precautions ( 5.3)] Because ...
-
8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - The limited available data on naloxone use in pregnant women are not sufficient to inform a drug-associated risk. However, there are clinical considerations ...
-
11 DESCRIPTIONNaloxone hydrochloride nasal spray is a pre-filled, single dose intranasal spray. Chemically, naloxone hydrochloride dihydrate is the hydrochloride salt of ...
-
12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites. Naloxone hydrochloride reverses the effects of ...
-
13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Long-term animal studies to evaluate the carcinogenic potential of naloxone have not been ...
-
16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied - Naloxone hydrochloride nasal spray 4 mg is supplied as a carton containing two blister packages (NDC 0093-2165-68) each with a single spray device. Naloxone hydrochloride ...
-
17 PATIENT COUNSELING INFORMATIONAdvise the patient and family members or caregivers to read the FDA-approved patient labeling ( Patient Informationand - Instructions for Use). Recognition of Opioid Overdose - Inform ...
-
PATIENT PACKAGE INSERTPATIENT INFORMATION - Naloxone Hydrochloride (nal ox’ one hye” droe klor’ ide) Nasal Spray - You and your family members or caregivers should read this Patient Information leaflet ...
-
PRINCIPAL DISPLAY PANELNDC 0093-2165-68 - 0.1 mL intranasal spray per unit - For use in the nose only - Rx only - Naloxone Hydrochloride Nasal Spray - 4 mg - Use Naloxone Hydrochloride Nasal Spray for ...
-
INGREDIENTS AND APPEARANCEProduct Information