{"active_ingredient":["Active ingredient (in each chewable tablet) Cetirizine HCl 10 mg"],"dosage_and_administration":["Directions • may be taken with or without water • chew or crush tablets completely before swallowing adults and children 6 years and over Chew and swallow 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 Other information • Store between 20ºC to 25º C (68ºF to 77º F)"],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"45%\"/><col width=\"45%\"/><tbody><tr><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>adults and children 6 years and over</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Chew and swallow 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. </paragraph></td></tr><tr><td styleCode=\"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=\"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=\"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":"20250630","id":"4b5cb5f2-f046-4a6f-abfc-da4280fce674","inactive_ingredient":["Inactive ingredients acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc and tutti frutti flavor Questions? 1-800-525-8747 Manufactured by Sandoz Private Limited, India for Sandoz Inc., Princeton, NJ 08540 Product of India Revised: 04/2026"],"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 Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["ANDA078692"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Sandoz Inc"],"package_ndc":["0781-5284-06","0781-5284-64"],"product_ndc":["0781-5284"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014674"],"spl_id":["4b5cb5f2-f046-4a6f-abfc-da4280fce674"],"spl_set_id":["a814a06b-96ed-4403-bbd7-fc1142988b50"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["Principal Display Panel NDC 0781-5284-64 Children's Cetirizine HCl Chewable Tablets 10 mg antihistamine Tutti Frutti Flavored 30 Chewable Tablets Do not use if individual blister unit is open or torn ALLERGY Indoor & Outdoor Allergies 6 yrs. and older 10 mg each 24 hour Relief of • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose No water needed Chew or crush tablets completely before swallowing cetirizine10mg"],"purpose":["Purpose Antihistamine"],"set_id":"a814a06b-96ed-4403-bbd7-fc1142988b50","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE ACESULFAME POTASSIUM BENZYL ALCOHOL BETADEX SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE, DL- FERRIC OXIDE RED FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE PROPYLENE GLYCOL TALC peach, mottled SZ;106"],"version":"5","warnings":["Warnings 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. 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 • 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 (1-800-222-1222). 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."]}