Label: NALOXONE HYDROCHLORIDE spray
- NDC Code(s): 69238-2104-1, 69238-2104-7
- Packager: Amneal Pharmaceuticals NY LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 9, 2025
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each spray)
- Purpose
- Use(s)
- Warnings
-
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
- Other information
- KEEP OUT OF REACH OF CHILDREN
- Inactive ingredients
- Questions or comments?
-
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
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
NALOXONE HYDROCHLORIDE
naloxone hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69238-2104 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N) NALOXONE HYDROCHLORIDE 4 mg in 0.1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) Product Characteristics Color white (clear, colorless to faintly yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69238-2104-7 2 in 1 CARTON 04/24/2024 1 NDC:69238-2104-1 0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217992 04/24/2024 Labeler - Amneal Pharmaceuticals NY LLC (123797875) Establishment Name Address ID/FEI Business Operations Amneal Pharmaceuticals, LLC 079823130 analysis(69238-2104) , label(69238-2104) , manufacture(69238-2104) , pack(69238-2104)
