{"active_ingredient":["ACTIVE INGREDIENT (in each tablet) Cetirizine HCl, USP 5 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":["DIRECTIONS Adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. Adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. 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 over1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours.
Adults 65 years and over1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
Children under 6 years of ageask a doctor
Consumers with liver or kidney diseaseask a doctor
"],"effective_time":"20240731","id":"79a66101-ea46-4515-bb20-ce790b750d70","inactive_ingredient":["INACTIVE INGREDIENTS 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":["65162-045-03","65162-045-50"],"product_ndc":["65162-045"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014676"],"spl_id":["79a66101-ea46-4515-bb20-ce790b750d70"],"spl_set_id":["214936a2-adc4-422a-a8fe-4c3ce9e01f36"],"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":"214936a2-adc4-422a-a8fe-4c3ce9e01f36","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;45"],"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, NJ08807 Rev. 07-2024-02"],"stop_use":["STOP USE Stop use and ask a doctor if an allergic reaction to this 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."]}