{"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":"20260114","id":"485f83f8-8404-eae8-e063-6294a90a3c33","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":["AvKARE"],"package_ndc":["42291-493-01","42291-493-02"],"product_ndc":["42291-493"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1725059"],"spl_id":["485f83f8-8404-eae8-e063-6294a90a3c33"],"spl_set_id":["1766a7f1-d301-945f-e063-6294a90ac6f4"],"substance_name":["NALOXONE HYDROCHLORIDE"],"unii":["F850569PQR"]},"package_label_principal_display_panel":["Principal Display Panel x xx"],"purpose":["Purpose Emergency treatment of opioid overdose"],"recent_major_changes":[""],"set_id":"1766a7f1-d301-945f-e063-6294a90ac6f4","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 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 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 hand 1 1 1 1 1"],"spl_product_data_elements":["Naloxone Hydrochloride Naloxone Hydrochloride BENZALKONIUM CHLORIDE EDETATE DISODIUM SODIUM CHLORIDE WATER HYDROCHLORIC ACID NALOXONE HYDROCHLORIDE NALOXONE 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":"2","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."]}