{"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.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><paragraph>&#x25AA; For use in the nose only </paragraph><paragraph>&#x25AA; Do not test nasal spray device before use </paragraph><paragraph>&#x25AA; 1 nasal spray device contains 1 dose of medicine </paragraph><paragraph>&#x25AA; 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_5c911a35-996a-4bcd-b81d-6cc8df1e28f8\"/></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=\"ID_942181d9-8d52-4f5b-8ff2-639e939b81fc\"/></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=\"ID_6a48709d-72bc-41b7-9dca-4d3966150000\"/></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><renderMultiMedia ID=\"id-72125034\" referencedObject=\"bb80da2b-99d8-4af0-8ec4-e3cd332004fe\"/></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=\"c54244bf-fdf6-41c7-a439-dd925c000da7\"/></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=\"ID_044a233a-5774-4328-a0ff-1ba471505567\"/></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":"20251119","id":"f2811e51-2239-492f-9e6e-bfe53668f877","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":["Strategic Sourcing Services LLC"],"package_ndc":["70677-1283-1"],"product_ndc":["70677-1283"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1725059"],"spl_id":["f2811e51-2239-492f-9e6e-bfe53668f877"],"spl_set_id":["577fbd57-7054-4536-86c1-d43bc99cc7b1"],"substance_name":["NALOXONE HYDROCHLORIDE"],"unii":["F850569PQR"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC 70677-1283-1 COMPARE TO NARCAN ® ACTIVE INGREDIENT* Foster & Thrive™ Original Prescription Strength Naloxone HCl Nasal Spray 4 mg Emergency Treatment of Opioid Overdose EASY TO USE CAN SAVE A LIFE Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency For use in nose only 2 SINGLE-DOSE NASAL SPRAY DEVICES 0.003 FL OZ (0.1mL) EACH *This product is not manufactured or distributed by Emergent Operations Ireland Limited, owner of the registered trademark Narcan. Safe to Use Even if Opioids are Not Present ©2023 McKesson Corporation Distributed by: McKesson Corp., via Strategic Sourcing Services LLC. Memphis, TN 38141 www.fosterandthrive.com Manufactured by Padagis ® Yeruham, Israel 64QJ8 FT C3 Rev 08-25 64Q00 RT QS4 carton"],"purpose":["Purpose Emergency treatment of opioid overdose"],"set_id":"577fbd57-7054-4536-86c1-d43bc99cc7b1","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 833-358-6431"],"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."]}