{"active_ingredient":["Active ingredient (in each tablet) Fexofenadine HCl 180 mg"],"ask_doctor":["Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose."],"do_not_use":["Do not use if you have ever had an allergic reaction to this product or any of its ingredients."],"dosage_and_administration":["Directions adults and children 12 years of age and over take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor"],"dosage_and_administration_table":["<table><col width=\"35%\"/><col width=\"66%\"/><tbody><tr><td valign=\"top\"><paragraph><content styleCode=\"bold\">adults and children 12 years of age and over</content></paragraph></td><td styleCode=\"Botrule Lrule Rrule Toprule\" valign=\"top\"><paragraph>take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours</paragraph></td></tr><tr><td valign=\"top\"><paragraph><content styleCode=\"bold\">children under 12 years of age</content></paragraph></td><td styleCode=\"Botrule Lrule Rrule\" valign=\"top\"><paragraph>do not use</paragraph></td></tr><tr><td valign=\"top\"><paragraph><content styleCode=\"bold\">adults 65 years of age and older</content></paragraph></td><td styleCode=\"Botrule Lrule Rrule\" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td valign=\"top\"><paragraph><content styleCode=\"bold\">consumers with kidney disease</content></paragraph></td><td styleCode=\"Botrule Lrule Rrule\" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20240910","id":"21be7a92-2648-b2bf-e063-6394a90ac580","inactive_ingredient":["Inactive ingredients anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide"],"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":["ANDA204507"],"brand_name":["Fexofenadine HCl"],"generic_name":["FEXOFENADINE HCL"],"is_original_packager":[true],"manufacturer_name":["Advanced Rx LLC"],"package_ndc":["80513-506-01"],"product_ndc":["80513-506"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["997420"],"spl_id":["21be7a92-2648-b2bf-e063-6394a90ac580"],"spl_set_id":["c067b335-79c5-4176-a0b3-bae02a0c23f8"],"substance_name":["FEXOFENADINE HYDROCHLORIDE"],"unii":["2S068B75ZU"],"upc":["0380513001382"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel NDC 80513-506-01 Compare to the active ingredient in Allegra ® Allergy 24 Hour Tablets * Non-Drowsy Allergy Relief Fexofenadine HCL 180 mg INDOOR & OUTDOOR ALLERGY 24-Hour Allergy Relief Of: Sneezing, runny nose Itchy, watery eyes Itchy throat or nose 100 Tablets *This product is not manufactured or distributed by the owner of the registered trademark Allegra ® Allergy 24 Hour Tablets. label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions? call toll free 1-800-630-8895"],"set_id":"c067b335-79c5-4176-a0b3-bae02a0c23f8","spl_product_data_elements":["Fexofenadine HCl Fexofenadine HCl ANHYDROUS LACTOSE SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE STEARIC ACID HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED FERRIC OXIDE RED TITANIUM DIOXIDE FERRIC OXIDE YELLOW FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SG202"],"spl_unclassified_section":["Distributed by: Advanced Rx LLC 1942 NE 163rd St North Miami Beach, FL 33162 U.S.A."],"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° and 25°C (68° and 77°F) protect from excessive moisture each tablet contains: sodium 8.2 mg this product meets the requirements of USP Dissolution Test 2 DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED"],"version":"1","warnings":["Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, 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 do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)"]}