{"active_ingredient":["Active Ingredient (in each spray) Naloxone hydrochloride 4 mg"],"dosage_and_administration":["Directions 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 • CALL 911 immediately after giving the 1st dose Step 4: WATCH & GIVE • WAIT 2-3 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 2-3 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 on Naloxone HCl Nasal Spray 4 mg, call Padagis ® at 1-866-634-9120 or go to www.padagis.com. 64Q00 RT QS2 holding nasal spray device Step 1 Step 2 Step 3 Step 4 Step 5"],"dosage_and_administration_table":["
Important:For use in the nose onlyDo not test nasal spray device before use1 nasal spray device contains 1 dose of medicineEach device sprays 1 time only
","
Step 1: CHECK if you suspect an overdose:• CHECKfor 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• HOLDthe nasal spray device with your thumb on the bottom of the plunger • INSERTthe nozzle into either NOSTRIL • PRESSthe plunger firmly to give the 1st dose •1 nasal spray device contains 1 dose
Step 3: CALL• CALL 911immediately after giving the 1st dose
Step 4: WATCH & GIVE• WAIT2-3 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 GIVEdoses every 2-3 minutes until the person wakes up •it is safe to keep giving doses
Step 5: STAY• STAYuntil ambulance arrives: even if the person wakes up • GIVEanother dose if the person becomes very sleepy again •You may need to give all the doses in the pack
"],"effective_time":"20260402","id":"4e580310-91b7-9fe4-e063-6394a90a5d83","inactive_ingredient":["Inactive Ingredients benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water"],"indications_and_usage":["Uses • to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin • this medicine can save a life"],"openfda":{"application_number":["ANDA211951"],"brand_name":["NALOXONE HYDROCHLORIDE"],"generic_name":["NALOXONE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["BluePoint Laboratories"],"package_ndc":["68001-645-45"],"product_ndc":["68001-645"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1725059"],"spl_id":["4e580310-91b7-9fe4-e063-6394a90a5d83"],"spl_set_id":["327004b0-560a-84d0-e063-6294a90aa743"],"substance_name":["NALOXONE HYDROCHLORIDE"],"unii":["F850569PQR"],"upc":["0368001645454"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC 68001-645-45 Naloxone HCl Nasal Spray 4 mg Emergency Treatment of Opioid Overdose Original Prescription Strength Easy to Use Can Save a Life Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency For use in nose only 2 SINGLE-DOSE NASAL SPRAY DEVICES 0.003 FL OZ (0.1mL) EACH Rev 01/2025 NDC 68001-645-45 Naloxone HCl Nasal Spray 4 mg Emergency Treatment of Opioid Overdose Original Prescription Strength Easy to Use Can Save a Life Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency For use in nose only 2 SINGLE-DOSE NASAL SPRAY DEVICES 0.003 FL OZ (0.1mL) EACH Rev 08/2025 01 08"],"purpose":["Purpose Emergency treatment of opioid overdose"],"set_id":"327004b0-560a-84d0-e063-6294a90aa743","spl_product_data_elements":["NALOXONE HYDROCHLORIDE naloxone hydrochloride BENZALKONIUM CHLORIDE EDETATE DISODIUM SODIUM CHLORIDE HYDROCHLORIC ACID WATER NALOXONE HYDROCHLORIDE NALOXONE"],"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 • the product is packaged in individually-sealed blisters. Do not use if the blister is open or torn, or if the device appears damaged","Questions? call 1-866-634-9120 or go to www.padagis.com"],"version":"3","warnings":["Warning 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"]}