Active Ingredient (In Each Spray)
Naloxone hydrochloride 4 mg
The following Structured Product Label (SPL) was submitted to the FDA by Avkare for the product Naloxone Hydrochloride (NDC 42291-493). 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, use(s), when using this product, directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Naloxone hydrochloride 4 mg
Emergency treatment of opioid overdose
some people may experience symptoms when they wake up, such as shaking, sweating, nausea, or feeling angry. This is to be expected.
Step 1: CHECK if you suspect an overdose
Step 2: GIVE 1st dose in the nose
Step 3: CALL 911
Step 4: WATCH & GIVE
Step 5: STAY
Naloxone Hydrochloride Nasal Spray, 4 mg
Emergency Treatment of Opioid Overdose
Important:
Step 1: CHECK if you suspect an overdose
Step 2: GIVE 1st dose in the nose
Step 3: CALL 911
Step 4: WATCH & GIVE
Step 5: STAY
For opioid emergencies, call 911.For questions or more information about Naloxone Hydrochloride Nasal Spray, contact
AvKARE at 1-855-361-3993.
Mfg. Rev. 03-2023-01 AV 05/23
benzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride
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