{"active_ingredient":["ACTIVE INGREDIENT(S) Levocetirizine dihydrochloride USP 5 mg"],"ask_doctor":["ASK A DOCTOR BEFORE USE IF YOU HAVE ever had trouble urinating or emptying your bladder"],"do_not_use":["DO NOT USE • if you have kidney disease • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine"],"dosage_and_administration":["DIRECTIONS adults 65 years of age and older ask a doctor adults and children 12 to 64 years of age take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6 to 11 years of age take ½ tablet (2.5 mg) once daily in the evening do not take more than ½ tablet (2.5 mg) in 24 hours children under 6 years of age do not use consumers with kidney disease do not use"],"dosage_and_administration_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"553.945\"><col width=\"43.8415366146459%\"/><col width=\"56.1584633853541%\"/><tbody><tr styleCode=\"Botrule\"><td align=\"justify\" styleCode=\"Lrule Rrule\" valign=\"top\"> adults 65 years of age and older   </td><td styleCode=\"Rrule\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Square\"><item>ask a doctor</item></list> </td></tr><tr styleCode=\"Botrule\"><td align=\"justify\" styleCode=\"Lrule Rrule\" valign=\"top\"> adults and children 12 to 64 years of age   </td><td styleCode=\"Rrule\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Square\"><item>take 1 tablet (5 mg) once daily in the evening  </item><item>do not take more than 1 tablet (5 mg) in 24 hours  </item><item>&#xBD; tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms</item></list> </td></tr><tr styleCode=\"Botrule\"><td align=\"justify\" styleCode=\"Lrule Rrule\" valign=\"top\"> children 6 to 11 years of age   </td><td styleCode=\"Rrule\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Square\"><item>take &#xBD; tablet (2.5 mg) once daily in the evening  </item><item>do not take more than &#xBD; tablet (2.5 mg) in 24 hours</item></list> </td></tr><tr styleCode=\"Botrule\"><td align=\"justify\" styleCode=\"Lrule Rrule\" valign=\"top\"> children under 6 years of age   </td><td styleCode=\"Rrule\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Square\"><item>do not use</item></list> </td></tr><tr><td align=\"justify\" styleCode=\"Lrule Rrule\" valign=\"top\"> consumers with kidney disease   </td><td styleCode=\"Rrule\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Square\"><item>do not use</item></list> </td></tr></tbody></table>"],"effective_time":"20230214","id":"f4ab9fca-5fb1-518a-e053-2a95a90a3420","inactive_ingredient":["INACTIVE INGREDIENTS colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide."],"indications_and_usage":["USE(S) temporarily relieves these symptoms due to hay fever or other respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat"],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Levocetirizine Dihydrochloride Tablets USP 5 mg-180 Tablets Compare to XYZAL ® Allergy 24HR Active Ingredient* Allergy Relief Levocetirizine Dihydrochloride Tablets, USP 5 mg Antihistamine 24 HOUR Relief of Sneezing Runny Nose Itchy Nose or Throat Itchy, Watery Eyes Original Prescription Strength 180 TABLETS levo"],"pregnancy_or_breast_feeding":["IF PREGNANT OR BREAST-FEEDING if breast-feeding: not recommended if pregnant: ask a health professional before use"],"purpose":["PURPOSE Antihistamine"],"set_id":"f4aba1d6-2516-3b8a-e053-2995a90a5626","spl_product_data_elements":["Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE MAGNESIUM STEARATE TITANIUM DIOXIDE HYPROMELLOSES POLYETHYLENE GLYCOL 400 POLYSORBATE 80 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE White to off white H;LL"],"spl_unclassified_section":["OTHER INFORMATION • store between 20° and 25°C (68° and 77°F) • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing • safety sealed: do not use if carton was opened or if individual blister unit is open or torn","QUESTIONS or COMMENTS? call 1-844-384-3723. Distributed by: Safrel Pharmaceuticals, LLC Bridgewater, NJ 08807 www.safrel.com"],"stop_use":["STOP USE AND ASK A DOCTOR IF • you have trouble urinating or emptying your bladder • an allergic reaction to this product occurs. Seek medical help right away."],"version":"1","warnings":[""],"when_using":["WHEN USING THIS PRODUCT drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"]}