{"active_ingredient":["Drug Facts Active ingredient (in each tablet) Cetirizine hydrochloride USP 10 mg"],"ask_doctor":["Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."],"do_not_use":["Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine."],"dosage_and_administration":["Directions Tablet melts in mouth. Can be taken with or without water. adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"dosage_and_administration_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"636.804\"><colgroup><col width=\"42.5751879699248%\"/><col width=\"57.4248120300752%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" align=\"justify\" valign=\"middle\">adults and children 6 years and over </td><td styleCode=\"Rrule\" align=\"justify\" valign=\"middle\">one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" align=\"justify\" valign=\"middle\">adults 65 years and over </td><td styleCode=\"Rrule\" align=\"justify\" valign=\"middle\">ask a doctor </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" align=\"justify\" valign=\"middle\">children under 6 years of age </td><td styleCode=\"Rrule\" align=\"justify\" valign=\"middle\">ask a doctor </td></tr><tr><td styleCode=\"Lrule Rrule\" align=\"justify\" valign=\"middle\">consumers with liver or kidney disease </td><td styleCode=\"Rrule\" align=\"justify\" valign=\"middle\">ask a doctor </td></tr></tbody></table>"],"effective_time":"20210506","id":"c6f65c7b-e626-4ef3-910d-03702cac03bf","inactive_ingredient":["Inactive ingredients betadex, citric acid anhydrous, colloidal silicon dioxide, crospovidone, dl-alpha-tocopherol, hydroxypropyl cellulose, magnesium stearate, maize maltodextrin, mannitol, microcrystalline cellulose, natural flavourings, sodium bicarbonate, sodium starch glycolate and sucralose. Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper 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":["ANDA213557"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"package_ndc":["58602-862-76"],"product_ndc":["58602-862"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1011482"],"spl_id":["c6f65c7b-e626-4ef3-910d-03702cac03bf"],"spl_set_id":["d9ebebb5-736a-4019-8c1a-030148de9d02"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (24 Orally Disintegrating Tablets) Blister Carton NDC 58602-862-76 PrimaryHealth *Compare to the active ingredient of Zyrtec ® Allergy Original Prescription Strength Cetirizine Hydrochloride Orally Disintegrating Tablets, USP 10 mg Antihistamine Allergy Dissolve Tabs Indoor + Outdoor Allergies 24 Hour Relief of : Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Melts In Your Mouth ORANGE FLAVOR Actual Size 24 Orally Disintegrating Tablets 10 mg each PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12 Orally Disintegrating Tablets) Blister Carton"],"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":"d9ebebb5-736a-4019-8c1a-030148de9d02","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE BETADEX ANHYDROUS CITRIC ACID SILICON DIOXIDE CROSPOVIDONE (35 .MU.M) .ALPHA.-TOCOPHEROL, DL- HYDROXYPROPYL CELLULOSE (110000 WAMW) MAGNESIUM STEARATE MALTODEXTRIN MANNITOL MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 SODIUM BICARBONATE SODIUM STARCH GLYCOLATE TYPE A POTATO SUCRALOSE CE;10"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["Other information store between 20° to 25°C (68° to 77°F). Avoid high humidity. do not use if carton or blister unit is opened or broken see side panel for lot number and expiration date"],"version":"2","warnings":["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"]}