{"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. Step 1 Step 2 holding nasal spray device Step 3 Step 4 Step 5"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"98%\"/><tbody><tr styleCode=\"Toprule\"><td valign=\"top\"><paragraph><content styleCode=\"bold\">Important:</content></paragraph><list listType=\"unordered\"><item><caption>&#x2022;</caption>For use in the nose only </item><item><caption>&#x2022;</caption>Do not test nasal spray device before use </item><item><caption>&#x2022;</caption>1 nasal spray device contains 1 dose of medicine </item><item><caption>&#x2022;</caption>Each device sprays 1 time only</item></list><paragraph>Do not test nasal spray device before use </paragraph><paragraph>1 nasal spray device contains 1 dose of medicine </paragraph><paragraph>Each device sprays 1 time only</paragraph></td></tr></tbody></table>","<table width=\"100%\"><col width=\"30%\"/><col width=\"46%\"/><col width=\"22%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><renderMultiMedia ID=\"id1161275073\" referencedObject=\"ID_98604c53-e63b-4777-924c-b08b86ccc74b\"/></td><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 1: CHECK if you suspect an overdose:</content></paragraph><paragraph><content styleCode=\"bold\">&#x2022; <content styleCode=\"underline\">CHECK</content></content> for a <content styleCode=\"underline\">suspected overdose</content>:   the person will not wake up or is very sleepy or not breathing well</paragraph><paragraph><content styleCode=\"bold\">&#x2022; </content>yell &#x201C;Wake up!&#x201D;</paragraph><paragraph><content styleCode=\"bold\">&#x2022; </content>shake the person gently</paragraph><paragraph><content styleCode=\"bold\">&#x2022; </content>if the person is not awake, go to Step 2</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-1917234869\" referencedObject=\"dc2184b2-02c6-4451-bd59-48a735ef0dfa\"/></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 2: GIVE 1st dose in the nose</content></paragraph><paragraph><content styleCode=\"bold\">&#x2022; <content styleCode=\"underline\">HOLD</content></content> the nasal spray device with your thumb on the bottom of the plunger</paragraph><paragraph><content styleCode=\"bold\">&#x2022; <content styleCode=\"underline\">INSERT</content></content> the nozzle into either NOSTRIL</paragraph><paragraph><content styleCode=\"bold\">&#x2022; <content styleCode=\"underline\">PRESS</content></content> the plunger firmly to give the 1st dose</paragraph><paragraph><content styleCode=\"bold\">&#x2022; </content>1 nasal spray device contains 1 dose</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id493605695\" referencedObject=\"d8ea2da6-413c-4fd3-a88d-c0bf2960778a\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-72125034\" referencedObject=\"da51f2ba-e073-4578-a4e5-a304030e757d\"/></td><td colspan=\"2\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 3: CALL</content></paragraph><paragraph><content styleCode=\"bold\">&#x2022; <content styleCode=\"underline\">CALL 911</content></content>immediately after giving the 1st dose</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id1502312045\" referencedObject=\"ID_6567df5d-9241-4080-a8d2-98152b64ad1d\"/></td><td colspan=\"2\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 4: WATCH &amp; GIVE</content></paragraph><paragraph><content styleCode=\"bold\">&#x2022; <content styleCode=\"underline\">WAIT</content></content>2-3 minutes after the 1st dose to give the medicine time to work</paragraph><paragraph><content styleCode=\"bold\">&#x2022; </content>if the person <content styleCode=\"underline\">wakes up</content>: Go to Step 5</paragraph><paragraph><content styleCode=\"bold\">&#x2022; </content>if the person does<content styleCode=\"underline\"> not wake up</content>:</paragraph><paragraph><content styleCode=\"bold\"> &#x2022; <content styleCode=\"underline\">CONTINUE TO GIVE</content></content> doses every 2-3 minutes until the person wakes up</paragraph><paragraph> <content styleCode=\"bold\">&#x2022; </content>it is safe to keep giving doses</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><renderMultiMedia ID=\"id-1592004741\" referencedObject=\"ce55758a-f3a2-4c56-a750-ed36577fbcb2\"/></td><td colspan=\"2\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 5: STAY</content></paragraph><paragraph><content styleCode=\"bold\">&#x2022; <content styleCode=\"underline\">STAY</content></content> until ambulance arrives: even if the person wakes up</paragraph><paragraph><content styleCode=\"bold\">&#x2022; <content styleCode=\"underline\">GIVE</content></content> another dose if the person becomes very sleepy again</paragraph><paragraph><content styleCode=\"bold\">&#x2022; </content>You may need to give all the doses in the pack</paragraph></td></tr></tbody></table>"],"effective_time":"20250831","id":"7232f412-39b6-47d5-8f9a-0c1559435a3f","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":["AMERISOURCE BERGEN"],"package_ndc":["46122-812-71"],"product_ndc":["46122-812"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1725059"],"spl_id":["7232f412-39b6-47d5-8f9a-0c1559435a3f"],"spl_set_id":["cce38c13-0d2f-49bb-94fa-6f2bbb4d5984"],"substance_name":["NALOXONE HYDROCHLORIDE"],"unii":["F850569PQR"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel Good Neighbor Pharmacy NDC 46122-812-71 Original Prescription Strength Naloxone HCl Nasal Spray 4 mg Emergency Treatment of Opioid Overdose Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency Easy to Use Can Save a Life For use in nose only 2 SINGLE-DOSE NASAL SPRAY DEVICES 0.003 FL OZ (0.1mL) EACH Safe to Use Even if Opioids are Not Present *Good Neighbor Pharmacy® Naloxone HCl Nasal Spray 4 mg is not manufactured or distributed by Emergent Operations Ireland Limited. Distributed By AmerisourceBergen 1 West First Avenue, Conshohocken, PA 19428 Questions or Concerns? www.mygnp.com Manufactured by Padagis ® Yeruham, Israel Product of USA 64QJ8 GP C2 64Q00 RT QS2 Naloxone HCl Nasal Spray 4 mg carton with instructions"],"purpose":["Purpose Emergency treatment of opioid overdose"],"set_id":"cce38c13-0d2f-49bb-94fa-6f2bbb4d5984","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."]}