{"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 sever 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 ID=\"id8e05bd6-ac0c-4513-874b-bfc06c77e708\" width=\"600\"><col width=\"45%\"/><col width=\"55%\"/><tbody><tr><td>Adults and children 6   years and over </td><td>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 sever symptoms.</td></tr><tr><td>Adults 65 years and over</td><td>Ask a doctor</td></tr><tr><td>Children under 6 years of age</td><td>Ask a doctor</td></tr><tr><td>Consumers with liver or kidney disease</td><td>Ask a doctor</td></tr></tbody></table>"],"effective_time":"20250306","id":"2fb2f0c8-a45a-5c2a-e063-6394a90a1587","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 Poison Control Center right away. ( 1-800-222-1222 )"],"openfda":{"application_number":["ANDA077829"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Umasuto, LLC"],"package_ndc":["85293-001-01"],"product_ndc":["85293-001"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["2fb2f0c8-a45a-5c2a-e063-6394a90a1587"],"spl_set_id":["9af4ab23-d6d3-43f9-a026-76fd9771963f"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0385293001010"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL-100'S COUNT UMASUTO NDC 85293-001-01 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 10 mg Compare to the active ingredient in Zyrtec Antihistamine ALLERGY Indoor & Outdoor Allergies 24 Hour Relief of: •Sneezing •Runny Nose •Itchy, Watery Eyes •Itchy Throat or Nose 6 yrs& older 100 Tablets container label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use."],"purpose":["Pupose Antihistamine"],"questions":["Questions? Call 1-866-768-0551"],"set_id":"9af4ab23-d6d3-43f9-a026-76fd9771963f","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride LACTOSE MAGNESIUM STEARATE STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE TITANIUM DIOXIDE HYPROMELLOSES CETIRIZINE HYDROCHLORIDE CETIRIZINE 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 Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India Distributed by: Umasuto, LLC 14130 Minnesota Avenue, Bonner Springs, KS 66012 Issued 03/2025"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"1","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."]}