{"active_ingredient":["OTC - ACTIVE INGREDIENT SECTION (IN EACH TABLET) For 5 mg Cetirizine HCl USP 5 mg For 10 mg Cetirizine HCl USP 10 mg"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION 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":["
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
","
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
"],"effective_time":"20181206","id":"d0cda4dc-2275-4366-bbc7-d3bc4c09bdd9","inactive_ingredient":["INACTIVE INGREDIENT Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide"],"indications_and_usage":["INDICATIONS AND USAGE 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":["OTC - KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Cetirizine Hydrochloride Tablets 5 mg-For Hives Relief Cetirizine Hydrochloride Tablets 10 mg-For Hives Relief Carton Carton"],"purpose":["OTC - PURPOSE SECTION Antihistamine"],"questions":["OTC - QUESTIONS call 1-866-562-4616"],"set_id":"a72b3687-8940-448b-a60f-2388f906a2b7","spl_product_data_elements":["cetirizine hydrochloride cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED STARCH, CORN TITANIUM DIOXIDE Rounded-off U;133","cetirizine hydrochloride cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED STARCH, CORN TITANIUM DIOXIDE Rounded-off U;134"],"spl_unclassified_section":["DRUG FACTS","Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Distributed by: Rochelle Park, NJ 07662. Company Logo"],"storage_and_handling":["STORAGE AND HANDLING store between 20° to 25° C (68° to 77° F)"],"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 occuring. 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. 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."]}