{"active_ingredient":["Cetirizine HCl 5 mg Cetirizine HCl 10 mg"],"dosage_and_administration":["Directions Cetirizine Hydrochloride Tablets, USP 5 mg adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours. adults 65 years and over 1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor 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=\"50%\"/><col width=\"50%\"/><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>1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours.</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>1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours.</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>","<table width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><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":"20260807","id":"42c1f2da-97b4-4583-bf62-368be53900c2","inactive_ingredient":["colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide"],"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":["ANDA078427"],"brand_name":["Cetirizine HCl"],"generic_name":["CETIRIZINE"],"is_original_packager":[true],"manufacturer_name":["GLENMARK THERAPEUTICS INC., USA"],"package_ndc":["72657-128-30","72657-128-45","72657-128-60","72657-128-70","72657-128-90","72657-128-08","72657-128-14","72657-128-15","72657-128-18","72657-128-24","72657-128-03","72657-128-35","72657-128-04","72657-128-81","72657-128-82","72657-128-84","72657-128-86","72657-128-41","72657-129-30","72657-129-45","72657-129-60","72657-129-70","72657-129-90","72657-129-08","72657-129-14","72657-129-15","72657-129-18","72657-129-24","72657-129-03","72657-129-35","72657-129-04","72657-129-81","72657-129-82","72657-129-84","72657-129-86","72657-129-41","72657-130-05","72657-131-89"],"product_ndc":["72657-128","72657-129","72657-130","72657-131"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014676","1014678"],"spl_id":["42c1f2da-97b4-4583-bf62-368be53900c2"],"spl_set_id":["04b08c52-5390-4cdb-a9e7-fca81fffdc73"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0372657129350"]},"other_safety_information":["Questions or comments? Call toll-free weekdays 9 AM to 5 PM EST at 1 (888) 721-7115. Distributed by: Glenmark Therapeutics Inc., USA Elmwood Park, NJ 07407 www.glenmarkpharma-us.com August 2026"],"package_label_principal_display_panel":["Package/Label Principal Display Panel Container label NDC 72657-129-35 10 mg - 365 Tablets label10mg365s","Principal Display Panel Carton label NDC 72657-129-35 10 mg - 365 Tablets carton10mg365s","Package/Label Principal Display Panel label10mg365s1","Package/Label Principal Display Panel carton10mg365s1"],"purpose":["Antihistamine"],"set_id":"04b08c52-5390-4cdb-a9e7-fca81fffdc73","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;13 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 Cetirizine HCl Cetirizine 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;13 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;13 Cetirizine HCl Cetirizine 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 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 of imprinted foil inner seal on bottle is broken or missing. • FDA approved organic impurities test procedure differs from USP"],"version":"7","warnings":["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 useif 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 • in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: • If breast-feeding: 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)"]}