{"active_ingredient":["Active ingredient (in each chewable tablet) 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 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=\"50%\" styleCode=\"Noautorules\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Toprule Rrule\">adults and children 6 years and over</td><td styleCode=\"Toprule\">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=\"Rrule\">adults 65 years and over</td><td>ask a doctor</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children under 6 years of age</td><td>ask a doctor</td></tr><tr><td styleCode=\"Rrule\">consumers with liver or kidney disease</td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20260603","id":"53580728-757e-08a5-e063-6394a90acb2e","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":{"application_number":["ANDA090142"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["OHM LABORATORIES INC."],"package_ndc":["51660-066-30"],"product_ndc":["51660-066"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014674"],"spl_id":["53580728-757e-08a5-e063-6394a90acb2e"],"spl_set_id":["97802669-b4bd-4807-b3c1-6c6f5a2b0c67"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0351660066302"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton Compare To the active ingredient of Children's Zyrtec ®† NDC 51660-066-30 ohm Laboratories Inc. (a SUN PHARMA company) Original Prescription Strength Children's Cetirizine Hydrochloride Chewable Tablets 10 mg Antihistamine Allergy Tutti-frutti Flavor Indoor & Outdoor Allergies 6 yrs & older Actual Size 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Chew or crush tablets completely before swallowing 30 CHEWABLE TABLETS cetirizine 10mg-30s"],"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"],"questions":["Questions? Call toll free 1-800-818-4555 weekdays"],"recent_major_changes":[""],"set_id":"97802669-b4bd-4807-b3c1-6c6f5a2b0c67","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride ACESULFAME POTASSIUM SILICON DIOXIDE SUCROSE CROSPOVIDONE (120 .MU.M) FD&C BLUE NO. 2 FD&C RED NO. 40 GUAR GUM MAGNESIUM OXIDE MAGNESIUM STEARATE MANNITOL MICROCRYSTALLINE CELLULOSE STARCH, CORN TALC CETIRIZINE HYDROCHLORIDE CETIRIZINE 344"],"spl_unclassified_section":["Drug Facts","Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901"],"stop_use":["Stop use and ask a 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 side panel for lot number and expiration date"],"version":"2","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. 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)"],"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."]}