{"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\"><colgroup><col width=\"43.8415366146459%\"/><col width=\"56.1584633853541%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" align=\"justify\" 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 styleCode=\"Lrule Rrule\" align=\"justify\" 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 styleCode=\"Lrule Rrule\" align=\"justify\" 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 styleCode=\"Lrule Rrule\" align=\"justify\" 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 styleCode=\"Lrule Rrule\" align=\"justify\" 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":"20201130","id":"7ca0cee0-b628-4266-b361-ad5c52b6f11e","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":{"application_number":["ANDA213513"],"brand_name":["Levocetirizine Dihydrochloride"],"generic_name":["LEVOCETIRIZINE DIHYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Camber Consumer Care Inc"],"package_ndc":["69230-321-31","69230-321-32","69230-321-33","69230-321-10","69230-321-01","69230-321-34"],"product_ndc":["69230-321"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["855172"],"spl_id":["7ca0cee0-b628-4266-b361-ad5c52b6f11e"],"spl_set_id":["be72dafb-62ae-40b2-874f-1d8920fad19d"],"substance_name":["LEVOCETIRIZINE DIHYDROCHLORIDE"],"unii":["SOD6A38AGA"],"upc":["0369230321317"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Levocetirizine Dihydrochloride Tablets USP 5 mg-35's Container carton 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 35 TABLETS Levocetirizine Dihydrochloride Tablets USP 5 mg - 35's Container label 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 35 TABLETS carton bottle label"],"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":"be72dafb-62ae-40b2-874f-1d8920fad19d","spl_product_data_elements":["Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE MAGNESIUM STEARATE TITANIUM DIOXIDE HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 400 POLYSORBATE 80 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 1-888-588-1418. Distributed by: Camber Consumer Care, Inc. Piscataway, NJ 08854, USA."],"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":"4","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"]}