{"active_ingredient":["Active ingredient (in each chewable tablet) For 5 mg: Cetirizine hydrochloride, USP 5 mg For 10 mg: Cetirizine hydrochloride, USP 10 mg"],"ask_doctor":["Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."],"do_not_use":["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."],"dosage_and_administration":["Directions may be taken with or without water chew or crush tablets completely before swallowing For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; 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 For 10 mg: adults and children 6 years and over Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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=\"892.43\" cellspacing=\"0\" cellpadding=\"0\"><col width=\"37.1087928464978%\"/><col width=\"62.8912071535022%\"/><tbody><tr styleCode=\"Botrule First\"><td styleCode=\"Lrule Rrule\" valign=\"top\">  adults and children 6 years and over </td><td styleCode=\"Rrule\" valign=\"top\">1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours.</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults 65 years and over</td><td styleCode=\"Rrule\" valign=\"top\">1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">children under 6 years of age</td><td styleCode=\"Rrule\" valign=\"top\">ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"top\">consumers with liver or kidney disease</td><td styleCode=\"Rrule\" valign=\"top\">ask a doctor</td></tr></tbody></table>","<table width=\"892.43\" cellspacing=\"0\" cellpadding=\"0\"><col width=\"37.1087928464978%\"/><col width=\"62.8912071535022%\"/><tbody><tr styleCode=\"Botrule First\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 6 years and over</td><td styleCode=\"Rrule\" valign=\"top\">Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet   (10 mg) in 24 hours. A 5 mg product may be appropriate for less severe symptoms. </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults 65 years and over</td><td styleCode=\"Rrule\" valign=\"top\">ask a doctor</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">children under 6 years of age</td><td styleCode=\"Rrule\" valign=\"top\">ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"top\">consumers with liver or kidney disease</td><td styleCode=\"Rrule\" valign=\"top\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20260714","id":"568fc395-5049-7c3d-e063-6394a90a2b65","inactive_ingredient":["Inactive ingredients acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose 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":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL For 5 mg Allergy: Original Prescription Strength NDC 47335-343-83 Cetirizine Hydrochloride Chewable Tablets 5 mg ALLERGY Antihistamine Indoor + Outdoor Allergies Actual Size Tutti-frutti Flavor 6 yrs & older 30 CHEWABLE TABLETS SUN PHARMACEUTICAL INDUSTRIES LTD. spl-cetirizine-5mg-allergy-1 spl-cetirizine-5mg-allergy-2 spl-cetirizine-5mg-allergy-3 spl-cetirizine-5mg-allergy-4 spl-cetirizine-5mg-allergy-5 spl-cetirizine-5mg-allergy-6 spl-cetirizine-5mg-allergy-7","PACKAGE LABEL.PRINCIPAL DISPLAY PANEL For 10 mg Allergy: Original Prescription Strength NDC 47335-344-83 Cetirizine Hydrochloride Chewable Tablets 10 mg ALLERGY Antihistamine Indoor & Outdoor Allergies Actual Size Tutti-frutti Flavor 6 yrs & older 30 CHEWABLE TABLETS SUN PHARMA spl-cetirizine-10mg-allergy-1 spl-cetirizine-10mg-allergy-22 spl-cetirizine-10mg-allergy-33"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use."],"purpose":["Purpose Antihistamine"],"set_id":"a4758152-97dd-4a27-b4d9-11178654b93e","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride ACESULFAME POTASSIUM SILICON DIOXIDE SUCROSE CROSPOVIDONE FD&C BLUE NO. 2 FD&C RED NO. 40 GUAR GUM MAGNESIUM OXIDE MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE STARCH, CORN TALC CETIRIZINE HYDROCHLORIDE CETIRIZINE 343 Cetirizine Hydrochloride Cetirizine Hydrochloride ACESULFAME POTASSIUM SILICON DIOXIDE SUCROSE CROSPOVIDONE FD&C BLUE NO. 2 FD&C RED NO. 40 GUAR GUM MAGNESIUM OXIDE MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE STARCH, CORN TALC CETIRIZINE HYDROCHLORIDE CETIRIZINE 344"],"spl_unclassified_section":["","Questions? Call toll free 1-800-818-4555 weekdays"],"stop_use":["Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["Other information store between 20° to 25°C (68° to 77°F) do not use if inner safety seal is open or torn see top layer for lot number and expiration date"],"version":"13","warnings":["Warnings"],"when_using":["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."]}