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Naloxone Hydrochloride drug information

NALOXONE HYDROCHLORIDE
Amneal Pharmaceuticals LLC · NASAL

Product NDC: 69238-2104

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameNALOXONE HYDROCHLORIDE
Labeler / manufacturerAmneal Pharmaceuticals LLC
RouteNASAL
Drug classDrug class not supplied in source label
Product NDC69238-2104
Label effective date2026-08-25

Official product label reference

Naloxone Hydrochloride — Amneal Pharmaceuticals LLC

This page contains 11 source sections for NALOXONE HYDROCHLORIDE, nasal route. Label set 8091a73d-9ecd-4578-a57b-5d85a2c5a16a, version 12.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Use(s) to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life

Purpose

Purpose Emergency treatment of opioid overdose
Dosage and administration — label text
Directions Step 1: CHECK if you suspect an overdose CHECK for a suspected overdose : the person will not wake up or is very sleepy or not breathing well yell “Wake up!” shake the person gently if the person is not awake, go to Step 2 Step 2: GIVE 1st dose in the nose HOLD the nasal spray device with your thumb on the bottom of the plunger INSERT the nozzle into either NOSTRIL PRESS the plunger firmly to give the 1st dose 1 nasal spray device contains 1 dose Step 3: CALL 911 CALL 911 immediately after giving the 1st dose Step 4: WATCH & GIVE WAIT 2 to 3 minutes after the 1st dose to give the medicine time to work if the person wakes up : Go to Step 5 if the person does not wake up : CONTINUE TO GIVE doses every 2 to 3 minutes until the person wakes up it is safe to keep giving doses Step 5: STAY STAY until ambulance arrives: even if the person wakes up GIVE another dose if the person becomes very sleepy again You may need to give all the doses in the pack 1 check 2 give 3 call step 4 5 stay
Warnings
Warnings 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.
Active ingredient
Active ingredient (in each spray) Naloxone hydrochloride 4 mg
While using this medicine
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.
Unclassified section
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 this product is packaged in individually-sealed blisters. Do not use if the blister is open or torn, or if the device appears damaged.
Child safety
Inactive ingredient
Inactive ingredients benzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride
Questions
Questions or comments? 1-877-835-5472 (Mon-Fri, 9AM-5PM EST)
Patient package insert
DIRECTIONS Naloxone Hydrochloride Nasal Spray, 4 mg 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 device sprays 1 time only Drug Facts Active ingredient (in each spray) Purpose Naloxone hydrochloride 4 mg .............................................................................................................................. 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 Step 1: CHECK if you suspect an overdose CHECK for a suspected overdose : the person will not wake up or is very sleepy or not breathing well yell “Wake up!” shake the person gently if the person is not awake, go to Step 2 Step 2: GIVE 1st dose in the nose HOLD the nasal spray device with your thumb on the bottom of the plunger INSERT the nozzle into either NOSTRIL PRESS the plunger firmly to give the 1st dose 1 nasal spray device contains 1 dose Step 3: CALL 911 CALL 911 immediately after giving the 1st dose Step 4: WATCH & GIVE WAIT 2 to 3 minutes after the 1st dose to give the medicine time to work if the person wakes up : Go to Step 5 if the person does not wake up : CONTINUE TO GIVE doses every 2 to 3 minutes until the person wakes up it is safe to keep giving doses Step 5: STAY STAY until ambulance arrives: even if the person wakes up GIVE another dose if the person becomes very sleepy again You may need to give all the doses in the pack Warnings 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 this product is packaged in individually-sealed blisters. Do not use if the blister is open or torn, or if the device appears damaged. Inactive ingredients benzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride Questions or comments? 1-877-835-5472 (Mon-Fri, 9AM-5PM EST) For opioid emergencies, call 911. For questions or more information about Naloxone Hydrochloride Nasal Spray, contact Amneal Pharmaceuticals at 1-877-835-5472. Rev. 11-2025-05 hand 1 check 2 give 3 call step 4 5 stay Table text from source: | Drug Facts | Active ingredient (in each spray) PurposeNaloxone hydrochloride 4 mg .............................................................................................................................. Emergency treatmentof opioid overdose | Usesto “revive” someone during an overdose from many prescription pain medications or street drugs such as herointhis medicine can save a life | WarningsWhen 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 informationstore at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F)do not freezeavoid excessive heat above 40°C (104°F)protect from lightthis product is packaged in individually-sealed blisters.Do not use if the blister is open or torn, or if the device appears damaged. | Inactive ingredientsbenzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride | Questions or comments?1-877-835-5472 (Mon-Fri, 9AM-5PM EST) | For opioid emergencies, call 911.For questions or more information about Naloxone Hydrochloride Nasal Spray, contact Amneal Pharmaceuticals at 1-877-835-5472. Rev. 11-2025-05

Official sources and product identifiers

Substances listed: NALOXONE HYDROCHLORIDE

RxNorm identifiers: 1725059

Package NDC codes

69238-2104-1, 69238-2104-7

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.