{"active_ingredient":["Active ingredient ​(in each tablet) Cetirizine HCl 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 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 width=\"100%\" cellspacing=\"0\" cellpadding=\"0\" border=\"0\"><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\">adults and children 6 years and over</td><td align=\"left\" styleCode=\"Rrule\">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 align=\"left\" styleCode=\"Lrule Rrule\">adults 65 years and over</td><td align=\"left\" styleCode=\"Rrule\">ask a doctor</td></tr><tr styleCode=\"Botrule\"><td align=\"left\" styleCode=\"Lrule Rrule\">children under 6 years of age</td><td align=\"left\" styleCode=\"Rrule\">ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\">consumers with liver or kidney disease</td><td align=\"left\" styleCode=\"Rrule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20260714","id":"569120e7-e21e-c7a2-e063-6394a90a2346","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide."],"indications_and_usage":["Uses reduces hives and 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":{"application_number":["ANDA209274"],"brand_name":["Cetirizine hydrochloride - HIVES"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Granules Pharmaceuticals Inc."],"package_ndc":["70010-293-14","70010-293-10","70010-293-56","70010-293-79"],"product_ndc":["70010-293"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["569120e7-e21e-c7a2-e063-6394a90a2346"],"spl_set_id":["562b5e6c-6103-df3d-e063-6394a90a897d"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL cetirizine-hives-14s-label.jpg cetirizine-hives-blister-carton.jpg cetirizine-hives-blist-foil.jpg"],"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 1-877-770-3183: Weekdays 9:00 AM to 4:30 PM EST"],"set_id":"562b5e6c-6103-df3d-e063-6394a90a897d","spl_product_data_elements":["Cetirizine hydrochloride - HIVES Cetirizine hydrochloride LACTOSE MONOHYDRATE CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE 2910 (5 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 CETIRIZINE HYDROCHLORIDE CETIRIZINE white to off white rounded off rectangualr G;4"],"spl_unclassified_section":["Cetirizine Hydrochloride Tablets Drug Facts","Other information ◾store between 20° to 25°C (68° to 77°F) ◾Contains no ingredient made from a gluten-containing grain (wheat, barley or rye)."],"stop_use":["Stop use and ask a 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"],"version":"2","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. 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. 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 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.  symptoms do not improve after 3 days of treatment  the hives have lasted more than 6 weeks 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."]}