{"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 1 st 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 1 st dose 1 nasal spray device contains 1 dose Step 3: CALL CALL 911 immediately after giving the 1 st dose Step 4: WATCH & GIVE WAIT 2-3 minutes after the 1 st 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":["<table width=\"552px\"><col width=\"21%\"/><col width=\"77%\"/><tbody><tr><td styleCode=\" Botrule Toprule Lrule Rrule\"><renderMultiMedia referencedObject=\"MM1\"/> </td><td styleCode=\" Botrule Toprule Lrule Rrule\" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 1: CHECK if you suspect an overdose:</content></paragraph><list listType=\"unordered\" styleCode=\"Square\"><item><content styleCode=\"bold\"><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 </item><item>yell &#x201C;Wake up!&#x201D;</item><item>shake the person gently</item><item>if the person is not awake, go to Step 2</item></list></td></tr><tr><td styleCode=\" Botrule Lrule Rrule\"><renderMultiMedia referencedObject=\"MM2\"/></td><td styleCode=\" Botrule Toprule Lrule Rrule\" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 2: GIVE 1 <sup>st</sup>dose in the nose </content></paragraph><list listType=\"unordered\" styleCode=\"Square\"><item><content styleCode=\"bold\"><content styleCode=\"underline\">HOLD</content></content>the nasal spray device with your thumb on the bottom of the plunger </item><item><content styleCode=\"bold\"><content styleCode=\"underline\">INSERT</content></content>the nozzle into either NOSTRIL </item><item><content styleCode=\"bold\"><content styleCode=\"underline\">PRESS</content></content>the plunger firmly to give the 1 <sup>st</sup>dose </item><item>1 nasal spray device contains 1 dose</item></list></td></tr><tr><td styleCode=\" Botrule Lrule Rrule\"><renderMultiMedia referencedObject=\"MM3\"/></td><td styleCode=\" Botrule Toprule Lrule Rrule\" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 3: CALL</content></paragraph><list listType=\"unordered\" styleCode=\"Square\"><item><content styleCode=\"bold\"><content styleCode=\"underline\">CALL 911</content></content>immediately after giving the 1 <sup>st</sup>dose </item></list></td></tr><tr><td styleCode=\" Botrule Lrule Rrule\" valign=\"top\"><renderMultiMedia referencedObject=\"MM4\"/></td><td styleCode=\" Botrule Toprule Lrule Rrule\" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 4: WATCH &amp; GIVE</content></paragraph><list listType=\"unordered\" styleCode=\"Square\"><item><content styleCode=\"bold\"><content styleCode=\"underline\">WAIT</content></content>2-3 minutes after the 1 <sup>st</sup>dose to give the medicine time to work </item><item>if the person <content styleCode=\"underline\">wakes up:</content>Go to Step 5 </item><item>if the person does <content styleCode=\"underline\">not wake up:</content></item></list><list listType=\"unordered\" styleCode=\"Square\"><item><content styleCode=\"bold\"><content styleCode=\"underline\">CONTINUE TO GIVE</content></content>doses every 2-3 minutes until the person wakes up </item><item>it is safe to keep giving doses</item></list></td></tr><tr><td styleCode=\" Botrule Toprule Lrule Rrule\" valign=\"top\"><renderMultiMedia referencedObject=\"MM5\"/></td><td styleCode=\" Botrule Toprule Lrule Rrule\" valign=\"top\"><paragraph><content styleCode=\"bold\">Step 5: STAY</content></paragraph><list listType=\"unordered\" styleCode=\"Square\"><item><content styleCode=\"bold\"><content styleCode=\"underline\">STAY</content></content>until ambulance arrives: even if the person wakes up </item><item><content styleCode=\"bold\"><content styleCode=\"underline\">GIVE</content></content>another dose if the person becomes very sleepy again </item><item>You may need to give all the doses in the pack</item></list></td></tr></tbody></table>"],"effective_time":"20241029","id":"259ab241-9f39-0383-e063-6394a90a040c","inactive_ingredient":["Inactive Ingredients benzalkonium chloride, edetate disodium, sodium chloride buffered with sodium hydroxide/hydrochloric acid, 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":[""],"openfda":{"application_number":["ANDA209522"],"brand_name":["Naloxone Hydrochloride"],"generic_name":["NALOXONE HYDROCHLORIDE"],"manufacturer_name":["Asclemed USA, Inc."],"original_packager_product_ndc":["0480-3478"],"package_ndc":["76420-867-02"],"product_ndc":["76420-867"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1725059"],"spl_id":["259ab241-9f39-0383-e063-6394a90a040c"],"spl_set_id":["7acf3bde-f858-4fbc-8a11-6741a3d27b8e"],"substance_name":["NALOXONE HYDROCHLORIDE"],"unii":["F850569PQR"]},"other_safety_information":["Other information Store below 77°F (25°C). 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."],"package_label_principal_display_panel":["Package/Label Principal Display Panel 4 mg"],"purpose":["Purpose Emergency treatment of opioid overdose"],"questions":["Questions? 1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday. www.tevausa.com/our-products/tevagenerics"],"set_id":"7acf3bde-f858-4fbc-8a11-6741a3d27b8e","spl_product_data_elements":["Naloxone Hydrochloride Naloxone Hydrochloride BENZALKONIUM CHLORIDE EDETATE DISODIUM SODIUM CHLORIDE HYDROCHLORIC ACID WATER NALOXONE HYDROCHLORIDE NALOXONE"],"spl_unclassified_section":["Safe to Use Even if Opioids are Not Present *This product is not affiliated with, manufactured by, or produced by the makers or owners of NARCAN ® Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501"],"spl_unclassified_section_table":["<table width=\"500px\" cellspacing=\"5\"><col/><tbody><tr styleCode=\"First Last\"><td align=\"center\" styleCode=\"Botrule Toprule\"> Safe to Use   Even if Opioids are Not Present </td></tr></tbody></table>"],"version":"1","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."]}