{"active_ingredient":["ACTIVE INGREDIENT (IN EACH SPRAY) Naloxone hydrochloride 4 mg"],"dosage_and_administration":["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":"20240530","id":"19b0603b-2420-f439-e063-6294a90ae85f","inactive_ingredient":["benzalkonium chloride, edetate disodium, hydrochloric acid, sodium chloride, water"],"indications_and_usage":["• 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"],"openfda":{"application_number":["ANDA211951"],"brand_name":["NALOXONE HYDROCHLORIDE"],"generic_name":["NALOXONE HYDROCHLORIDE"],"manufacturer_name":["HF Acquisition Co LLC, DBA HealthFirst"],"original_packager_product_ndc":["45802-578"],"package_ndc":["51662-1659-1","51662-1659-2"],"product_ndc":["51662-1659"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1725059"],"spl_id":["19b0603b-2420-f439-e063-6294a90ae85f"],"spl_set_id":["19b0603b-241f-f439-e063-6294a90ae85f"],"substance_name":["NALOXONE HYDROCHLORIDE"],"unii":["F850569PQR"]},"package_label_principal_display_panel":["NDC 51662-1659-1 UNBOXED","NDC 51662-1659-2 CARTON LABEL RFID Label"],"purpose":["Emergency treatment of opioid overdose"],"questions":["QUESTIONS? call 1-866-634-9120 or go to www.padagis.com"],"set_id":"19b0603b-241f-f439-e063-6294a90ae85f","spl_product_data_elements":["NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE WATER BENZALKONIUM CHLORIDE EDETATE DISODIUM HYDROCHLORIC ACID SODIUM CHLORIDE NALOXONE HYDROCHLORIDE NALOXONE"],"spl_unclassified_section":["USES • to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin • this medicine can save a life","DIRECTIONS Directions","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"],"version":"1","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."]}