{"active_ingredient":["Cetirizine HCl 10 mg"],"dosage_and_administration":["Cetirizine Hydrochloride Tablets, USP 10 mg 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 width=\"100%\"><col width=\"49%\"/><col width=\"49%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults and children 6 years and over</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.</paragraph><paragraph>A 5 mg product may be appropriate for less severe symptoms.</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>adults 65 years and over</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children under 6 years of age</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>consumers with liver or kidney disease</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20250404","id":"2e9de837-00b0-491d-a2e3-766fab46380a","inactive_ingredient":["colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide."],"indications_and_usage":["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":["ANDA078427"],"brand_name":["Cetirizine HCl"],"generic_name":["CETIRIZINE"],"is_original_packager":[true],"manufacturer_name":["Strategic Sourcing Services LLC"],"package_ndc":["70677-1279-2","70677-1279-3","70677-1279-4","70677-1279-5","70677-1279-1"],"product_ndc":["70677-1279"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["2e9de837-00b0-491d-a2e3-766fab46380a"],"spl_set_id":["65b37b00-8efc-4e04-ab97-a03e8af27d33"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"other_safety_information":["Questions or comments? Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India Distributed by: McKesson Corp. via SSSL Memphis, TN 38141 www.fosterandthrive.com Product of India April 2025"],"package_label_principal_display_panel":["Package/Label Principal Display Panel Container label NDC 70677-1279-5 10 mg - 300 Tablets label10mg300s","Package/Label Principal Display Panel Carton label NDC 70677-1279-5 10 mg- 300 Tablets carton10mg300s"],"purpose":["Antihistamine"],"set_id":"65b37b00-8efc-4e04-ab97-a03e8af27d33","spl_product_data_elements":["Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;17"],"spl_unclassified_section":["Other information • store between 20°C to 25°C (68°F to 77°F) • do not use if imprinted foil inner seal on bottle is broken or missing. • FDA approved organic impurities test procedure differs from USP"],"version":"3","warnings":["Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives 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 Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breastfeeding: • If breastfeeding: not recommended • if pregnant: ask a health professional before use. 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)."]}