{"active_ingredient":["Active ingredient (in each capsule) Cetirizine HCl USP, 10 mg"],"dosage_and_administration":["Directions adults and children 6 years and over One 10 mg capsule once daily; do not take more than one 10 mg capsule 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 ID=\"ID16\" width=\"590\"><col width=\"295\"/><col width=\"295\"/><tbody><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\">adults and children 6 years and over</td><td align=\"left\" styleCode=\"Botrule Rrule Toprule\" valign=\"top\"><paragraph>One 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. </paragraph><paragraph>A 5 mg product may be appropriate for less severe symptoms.</paragraph></td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\" valign=\"top\">adults 65 years and over</td><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">ask a doctor</td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\" valign=\"top\">children under 6 years of age</td><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">ask a doctor</td></tr><tr><td align=\"left\" styleCode=\"Botrule Lrule Rrule\" valign=\"top\">consumers with liver or kidney disease</td><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20260824","id":"59c7dbe5-bf71-fd55-e063-6294a90a7635","inactive_ingredient":["Inactive ingredients gelatin, medium chain triglyceride, polyethylene glycol 400, printing ink white (isopropyl alcohol, propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide) purified water, sodium hydroxide, sorbitol-sorbitan solution."],"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":["ANDA205291"],"brand_name":["cetirizine hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Strides Pharma, Inc."],"package_ndc":["59556-894-12","59556-894-77","59556-894-79","59556-894-78"],"product_ndc":["59556-894"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014675"],"spl_id":["59c7dbe5-bf71-fd55-e063-6294a90a7635"],"spl_set_id":["29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0359556894770"]},"other_safety_information":["Other Information store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) protect from light Do not use if Tamper-Evident seal under cap imprinted with \"Sealed for your Protection\" is broken or missing."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Cetirizine HCL Capsules, 10mg Antihistamine Allergy -Original Prescription Strength -24 Hour Relief of Runny nose Sneezing Itchy, watery eyes Itching of the nose or throat -INDOOR & OUTDOOR ALLERGIES 12 Liquid Filled Capsules -Carton Label 12 Liquid Filled Capsules -Container Label 25 Liquid Filled Capsules -Carton Label 25 Liquid Filled Capsules -Container Label 40 Liquid Filled Capsules -Carton Label 40 Liquid Filled Capsules -Container Label 7000 Liquid Filled Capsules -Carton Label (Transit Pack) carton-12s container-12s-part-1-top container-12s-part-1-back container-12s-part-2-top container-12s-part-2-back container-12s-base-label carton-25s container-25s-part-1-top container-25s-part-1-back container-25s-part-2-top container-25s-part-2-back container-25s-base-label carton-40s container-40s-top container-40s-base-label carton-7000s-bulk-label"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? call 1-877-244-9825 Distributed by: Strides Pharma, Inc Bridgewater, NJ 08807. Revised: 08/2026"],"set_id":"29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba","spl_product_data_elements":["cetirizine hydrochloride cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE GELATIN ISOPROPYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL SHELLAC SODIUM HYDROXIDE SODIUM LAURYL SULFATE SORBITAN SORBITOL TITANIUM DIOXIDE WATER colorless to pale yellow 291"],"version":"4","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. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use."]}