{"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 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"],"dosage_and_administration_table":["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 onlyDo not test nasal spray device before use 1 nasal spray device contains 1 dose of medicine Each device sprays 1 time only
Important:
••••
","
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 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 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
"],"effective_time":"20241003","how_supplied":["HOW SUPPLIED Naloxone HCl Nasal Spray 4 mg NDC: 72162-2376-2: 2 Single-Dose Vials in a Carton Store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F) Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504"],"id":"fbe83ce1-e79c-417d-a2f2-432c96e6f1f1","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"],"manufacturer_name":["Bryant Ranch Prepack"],"original_packager_product_ndc":["45802-578"],"package_ndc":["72162-2376-4","72162-2376-2"],"product_ndc":["72162-2376"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1725059"],"spl_id":["fbe83ce1-e79c-417d-a2f2-432c96e6f1f1"],"spl_set_id":["ed549649-dcbd-41f7-a774-876906751c5a"],"substance_name":["NALOXONE HYDROCHLORIDE"],"unii":["F850569PQR"]},"package_label_principal_display_panel":["Naloxone HCl 4mg Nasal Spray #2 Label Extended Label"],"purpose":["Purpose Emergency treatment of opioid overdose"],"set_id":"ed549649-dcbd-41f7-a774-876906751c5a","spl_product_data_elements":["NALOXONE HYDROCHLORIDE naloxone hydrochloride NALOXONE HYDROCHLORIDE NALOXONE BENZALKONIUM CHLORIDE EDETATE DISODIUM SODIUM CHLORIDE HYDROCHLORIC ACID WATER holding nasal spray device Step 1 Step 2 Step 3 Step 4 Step 5"],"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":"100","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"]}