{"active_ingredient":["ACTIVE INGREDIENT (in each tablet) Cetirizine HCl, USP 10 mg"],"ask_doctor":["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 DOCTOR/PHARMACIST 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"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION 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":["
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 sever 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":"20240731","id":"b1326566-e6ae-44c3-a1c5-3b0f5be3fc1f","inactive_ingredient":["INACTIVE INGREDIENT Inactive ingredients lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide."],"indications_and_usage":["INDICATIONS AND USAGE 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 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":["ANDA078780"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE"],"is_original_packager":[true],"manufacturer_name":["Amneal Pharmaceuticals LLC"],"package_ndc":["65162-046-03","65162-046-50"],"product_ndc":["65162-046"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["b1326566-e6ae-44c3-a1c5-3b0f5be3fc1f"],"spl_set_id":["273172b2-9aaf-46fb-a1ce-2961650eacd3"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Label Carton"],"pregnancy_or_breast_feeding":["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":["OTC - QUESTIONS Questions or Comments? Call 1-877-835-5472 Monday through Friday 9AM-5PM EST"],"set_id":"273172b2-9aaf-46fb-a1ce-2961650eacd3","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE STARCH, CORN TALC TITANIUM DIOXIDE IP;46"],"spl_unclassified_section":["Drug Facts","OTHER INFORMATION Other information • store between 20 to 25°C (68 to 77°F)","Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 07-2024-01"],"stop_use":["STOP USE Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"7","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."]}