{"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 • 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 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":"20231227","how_supplied":["HOW SUPPLIED Product: 50090-6963 NDC: 50090-6963-0 .1 mL in a VIAL, SINGLE-DOSE / 2 in a CARTON"],"id":"7a0088db-1e25-49db-9a22-c99cd6adfd8f","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"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN Keep this and all medications out of the reach of children."],"openfda":{"application_number":["ANDA211951"],"brand_name":["NALOXONE HYDROCHLORIDE"],"generic_name":["NALOXONE HYDROCHLORIDE"],"manufacturer_name":["A-S Medication Solutions"],"original_packager_product_ndc":["45802-578"],"package_ndc":["50090-6963-0"],"product_ndc":["50090-6963"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1725059"],"spl_id":["7a0088db-1e25-49db-9a22-c99cd6adfd8f"],"spl_set_id":["46f27d04-d4d2-4ef1-9cc5-4d58f4056f06"],"substance_name":["NALOXONE HYDROCHLORIDE"],"unii":["F850569PQR"]},"package_label_principal_display_panel":["naloxone hydrochloride Label Image"],"purpose":["Purpose Emergency treatment of opioid overdose"],"set_id":"46f27d04-d4d2-4ef1-9cc5-4d58f4056f06","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":"2","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."]}