{"active_ingredient":["Active Ingredient (in each tablet) Cetirizine HCl 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."],"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":["
Adults and children 6 years and overone 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 overAsk a doctor
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk a doctor
"],"effective_time":"20240725","how_supplied":["HOW SUPPLIED NDC: 71335-0300-1: 30 Tablets in a BOTTLE NDC: 71335-0300-2: 14 Tablets in a BOTTLE NDC: 71335-0300-3: 7 Tablets in a BOTTLE NDC: 71335-0300-4: 10 Tablets in a BOTTLE NDC: 71335-0300-5: 15 Tablets in a BOTTLE NDC: 71335-0300-6: 90 Tablets in a BOTTLE NDC: 71335-0300-7: 20 Tablets in a BOTTLE NDC: 71335-0300-8: 60 Tablets in a BOTTLE NDC: 71335-0300-9: 100 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504"],"id":"80b8a53e-8bc2-4bd7-b002-a7736af37618","inactive_ingredient":["Inactive ingredients Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide."],"indications_and_usage":["Uses: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose sneezing 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":["ANDA077829"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"manufacturer_name":["Bryant Ranch Prepack"],"original_packager_product_ndc":["16571-402"],"package_ndc":["71335-0300-1","71335-0300-2","71335-0300-3","71335-0300-4","71335-0300-5","71335-0300-6","71335-0300-7","71335-0300-8","71335-0300-9"],"product_ndc":["71335-0300"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["80b8a53e-8bc2-4bd7-b002-a7736af37618"],"spl_set_id":["4b192084-dfdc-47bc-a968-6f49e137b248"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["Cetirizine Hydrochloride 10 mg Tablet Label"],"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 1-844-874-7464"],"set_id":"4b192084-dfdc-47bc-a968-6f49e137b248","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE HYPROMELLOSE, UNSPECIFIED LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED TITANIUM DIOXIDE White Barrel Shaped CTN;10"],"spl_unclassified_section":["Other Information: store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].","Manufactured by: Unique Pharmaceutical Labs. (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 M. L. G/1430 Jul. 2020 126406"],"stop_use":["Stop use and ask a doctor if an allergic reaction tothis product occurs. Seek medical help right away."],"version":"9","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."],"when_using":["When using this product drowsines may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinary."]}