{"active_ingredient":["Cetirizine Hydrochloride 10 mg"],"ask_doctor_or_pharmacist":["Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"description":["QUESTIONS 1-855-221-5332: Weekdays 9AM - 5PM EST"],"do_not_use":["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."],"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 border=\"0\"><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 severe 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":"20260603","id":"5359e5b7-5279-c7fc-e063-6394a90a378b","inactive_ingredient":["Hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate, povidone, pregelatinized starch, and 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 (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA076047"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["First Nation Group, LLC"],"package_ndc":["81469-353-90","81469-353-03","81469-353-05","81469-353-01"],"product_ndc":["81469-353"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["5359e5b7-5279-c7fc-e063-6394a90a378b"],"spl_set_id":["5267f7c0-e62f-35da-e063-6394a90a9346"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["NDC 81469-353-01 Compares to Zyrtec®Allergy Original Prescription Strength Indoor & Outdoor Allergies Cetirizine HCl Tablets, USP 100 Tablets 10mg/ Antihistamine 24 Hour Relief of Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat or Nose FIRSTNATION Group Observation Media"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use."],"purpose":["Antihistamine"],"set_id":"5267f7c0-e62f-35da-e063-6394a90a9346","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride HYPROMELLOSES POVIDONE K30 POLYSORBATE 80 CETIRIZINE HYDROCHLORIDE CETIRIZINE POLYETHYLENE GLYCOL 400 MAGNESIUM STEARATE STARCH, CORN LACTOSE MONOHYDRATE TITANIUM DIOXIDE C;2"],"spl_unclassified_section":["DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Manufactured For: First Nation Group, LLC 4566 E Highway 20, Suite #208, Niceville, FL 32578-8839 * This product is not manufactured or distributed by Kenvue Brands LLC., the owner of the registered trademark Zyrtec®."],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["OTHER INFORMATION Store between 20° to 25°C (68° to 77°F)"],"version":"2","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. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. 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. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["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."]}