{"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":["<table ID=\"id8e05bd6-ac0c-4513-874b-bfc06c77e708\" width=\"600\" cellspacing=\"0\" cellpadding=\"0\"><colgroup/><tbody><tr styleCode=\"Botrule First\"><td styleCode=\"Lrule Rrule\" valign=\"middle\">Adults and children 6 years and over</td><td styleCode=\"Rrule\" valign=\"middle\">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=\"middle\">Adults 65 years and over</td><td styleCode=\"Rrule\" valign=\"middle\">Ask a doctor</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\">Children under 6 years of age</td><td styleCode=\"Rrule\" valign=\"middle\">Ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"middle\">Consumers with liver or kidney disease</td><td styleCode=\"Rrule\" valign=\"middle\">Ask a doctor</td></tr></tbody></table>"],"effective_time":"20251105","id":"538948d8-34aa-4460-8d66-ee8fcf4c60ab","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"],"is_original_packager":[true],"manufacturer_name":["Rising Pharma Holdings, Inc."],"package_ndc":["16571-402-10","16571-402-30","16571-402-50"],"product_ndc":["16571-402"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["538948d8-34aa-4460-8d66-ee8fcf4c60ab"],"spl_set_id":["5481ccb3-b311-4b25-b923-4fe8522ea92b"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL-100'S COUNT Rising® 16571-402-10 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 10 mg 6 yrs & older Antihistamine ALLERGY Indoor & Outdoor Allergies 24 Hour Relief of: •Sneezing •Runny Nose •Itchy, Watery Eyes •Itchy Throat or Nose 100 Tablets M.L. G/1430 cetrizine-10mg-100ct-1 cetrizine-10mg-100ct-2 cetrizine-10mg-100ct-3","M.L. G/25/2188 cetrizine-10mg-100ct-4 cetrizine-10mg-100ct-5 cetrizine-10mg-100ct-6","PRINCIPAL DISPLAY PANEL-300'S COUNT Rising® 16571-402-30 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 10 mg 6 yrs & older Antihistamine ALLERGY Indoor & Outdoor Allergies 24 Hour Relief of: •Sneezing •Runny Nose •Itchy, Watery Eyes •Itchy Throat or Nose 300 Tablets M.L.G/1430 cetrizine-10mg-300ct-1 cetrizine-10mg-300ct-2 cetirizine-10mg-300ct-3","PRINCIPAL DISPLAY PANEL-500'S COUNT Rising® 16571-402-50 Original Prescription Strength Cetirizine Hydrochloride Tablets USP 10 mg 6 yrs & older Antihistamine ALLERGY Indoor & Outdoor Allergies 24 Hour Relief of: •Sneezing •Runny Nose •Itchy, Watery Eyes •Itchy Throat or Nose 500 Tablets M.L. G/1430 cetrizine-10mg-500ct-1 cetrizine-10mg-500ct-2 cetrizine-10mg-500ct-3","PRINCIPAL DISPLAY PANEL-500'S COUNT M.L. G/25/2188 cetrizine-10mg-500ct-4 cetrizine-10mg-500ct-5 cetrizine-10mg-500ct-6"],"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":"5481ccb3-b311-4b25-b923-4fe8522ea92b","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine hypromelloses lactose magnesium stearate starch, corn polyethylene glycol povidone titanium dioxide White to off-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"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"13","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."]}