{"active_ingredient":["Active ingredient (in each spray) Naloxone hydrochloride 4 mg"],"dosage_and_administration":["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"],"effective_time":"20260825","id":"38da0633-039b-450a-9b04-592db2238396","inactive_ingredient":["Inactive ingredients benzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride"],"indications_and_usage":["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"],"keep_out_of_reach_of_children":[""],"openfda":{"application_number":["ANDA217992"],"brand_name":["Naloxone Hydrochloride"],"generic_name":["NALOXONE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Amneal Pharmaceuticals LLC"],"package_ndc":["69238-2104-1","69238-2104-7"],"product_ndc":["69238-2104"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1725059"],"spl_id":["38da0633-039b-450a-9b04-592db2238396"],"spl_set_id":["8091a73d-9ecd-4578-a57b-5d85a2c5a16a"],"substance_name":["NALOXONE HYDROCHLORIDE"],"unii":["F850569PQR"],"upc":["0369238210477"]},"package_label_principal_display_panel":["Principal Display Panel carton"],"purpose":["Purpose Emergency treatment of opioid overdose"],"questions":["Questions or comments? 1-877-835-5472 (Mon-Fri, 9AM-5PM EST)"],"set_id":"8091a73d-9ecd-4578-a57b-5d85a2c5a16a","spl_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"],"spl_patient_package_insert_table":["
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
"],"spl_product_data_elements":["Naloxone Hydrochloride Naloxone Hydrochloride NALOXONE HYDROCHLORIDE NALOXONE BENZALKONIUM CHLORIDE EDETATE DISODIUM SODIUM CHLORIDE WATER HYDROCHLORIC ACID clear, colorless to faintly yellow"],"spl_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."],"version":"12","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."],"when_using":["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."]}