{"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.padagisnaloxone.com. Step 1 Step 2 Step 3 Step 4 Step 5"],"dosage_and_administration_table":["
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":"20260106","id":"10534467-f259-44bb-bdf7-b09de54411ed","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":["Padagis Israel Pharmaceuticals Ltd"],"package_ndc":["45802-578-00","45802-578-84","45802-578-24"],"product_ndc":["45802-578"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1725059"],"spl_id":["10534467-f259-44bb-bdf7-b09de54411ed"],"spl_set_id":["b5d40220-f194-4835-b70c-f304ecb222d5"],"substance_name":["NALOXONE HYDROCHLORIDE"],"unii":["F850569PQR"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC 45802-578-84 Compare to NARCAN ® active ingredient Padagis Naloxone 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 2 SINGLE-DOSE NASAL SPRAY DEVICES 0.003 FL OZ (0.1mL) EACH FOR USE IN 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 SAFE TO USE EVEN IF OPIOIDS ARE NOT PRESENT Distributed by Padagis ® Allegan, MI 49010 www.padagisnaloxone.com 64QJ8 RT C4 Product of USA 64Q00 RT QS5 carton"],"purpose":["Purpose Emergency treatment of opioid overdose"],"set_id":"b5d40220-f194-4835-b70c-f304ecb222d5","spl_product_data_elements":["NALOXONE HYDROCHLORIDE naloxone hydrochloride NALOXONE HYDROCHLORIDE NALOXONE BENZALKONIUM CHLORIDE EDETATE DISODIUM SODIUM CHLORIDE HYDROCHLORIC ACID WATER"],"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":"5","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."]}