{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "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" ], "active_ingredient": [ "Cetirizine HCl 5 mg Cetirizine HCl 10 mg" ], "purpose": [ "Antihistamine" ], "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" ], "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)" ], "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)" ], "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": [ "
adults and children 6 years and over1 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 over1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
", "
adults and children 6 years and overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
" ], "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" ], "inactive_ingredient": [ "colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide" ], "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" ], "set_id": "04b08c52-5390-4cdb-a9e7-fca81fffdc73", "id": "42c1f2da-97b4-4583-bf62-368be53900c2", "effective_time": "20260807", "version": "7", "openfda": { "application_number": [ "ANDA078427" ], "brand_name": [ "Cetirizine HCl" ], "generic_name": [ "CETIRIZINE" ], "manufacturer_name": [ "GLENMARK THERAPEUTICS INC., USA" ], "product_ndc": [ "72657-128", "72657-129", "72657-130", "72657-131" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CETIRIZINE HYDROCHLORIDE" ], "rxcui": [ "1014676", "1014678" ], "spl_id": [ "42c1f2da-97b4-4583-bf62-368be53900c2" ], "spl_set_id": [ "04b08c52-5390-4cdb-a9e7-fca81fffdc73" ], "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" ], "is_original_packager": [ true ], "upc": [ "0372657129350" ], "unii": [ "64O047KTOA" ] } } ] }