{"active_ingredient":["Active ingredient (in each chewable tablet) For 5 mg: Cetirizine hydrochloride 5 mg For 10 mg: Cetirizine hydrochloride 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. hives that are an unusual color, look bruised or blistered hives that do not itch"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."],"do_not_use":["Do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. 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 For 5 mg: adults and children 6 years and over 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. adults 65 years and over 1 tablet once a day; do not take more than 1 tablet 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 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":["<table cellspacing=\"0\" cellpadding=\"0\"><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 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets 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 once a day; do not take more than 1 tablet 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 cellspacing=\"0\" cellpadding=\"0\"><tbody><tr styleCode=\"Botrule First\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 6 years and over</td><td styleCode=\"Rrule\" valign=\"top\">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.</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":"20241209","id":"780b12b3-7c49-4f10-8d49-e5aac217273a","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 relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring."],"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":["Principal Display Panel For 5 mg Hives Relief: Original Prescription Strength NDC 47335-343-16 Children's Cetirizine Hydrochloride Chewable Tablets 5 mg HIVES Relief Antihistamine 24 hour Relief of ITCHING Due to Hives Tutti-frutti Flavor 6 yrs. & older 100 CHEWABLE TABLETS SUN PHARMACEUTICAL INDUSTRIES LTD. For 10 mg Hives Relief: Original Prescription Strength NDC 47335-344-16 Children's Cetirizine Hydrochloride Chewable Tablets 10 mg HIVES Relief Antihistamine Tutti-frutti Flavor 6 yrs. & older 100 CHEWABLE TABLETS SUN PHARMACEUTICAL INDUSTRIES LTD. label-5mg-hives-1 label-5mg-hives-2 label-5mg-hives-3 label-5mg-hives-4 label-5mg-hives-5 label-10mg-hives-1 label-10mg-hives-2 label-10mg-hives-3 label-10mg-hives-4 label-10mg-hives-5"],"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":"54812a5b-ce4a-47ff-a481-0ed36ca17f5d","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE 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 343 Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE 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 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. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks"],"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":"3","warnings":["Warnings Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times."],"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"]}