{"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 180 mg 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 styleCode=\"Botrule Lrule Toprule \" valign=\"top\"> <paragraph>adults and children 12 years of age and over</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"> <paragraph>take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours</paragraph> </td> </tr> <tr> <td styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>children under 12 years of age</paragraph> </td> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>do not use</paragraph> </td> </tr> <tr> <td styleCode=\"Lrule Botrule \" valign=\"top\"> <paragraph>adults 65 years of age and older</paragraph> </td> <td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule Lrule \" valign=\"top\"> <paragraph>consumers with kidney disease</paragraph> </td> <td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20180222","id":"3d1fb3b4-2b84-44b1-99db-507802cf7968","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • 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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 180mg NDC 71610-041 Fexofenadine 180mg - Rx Only Bottle Label 180mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"8b5effa8-7ee3-4188-8b3a-8b62d4282c76","spl_product_data_elements":["fexofenadine hydrochloride fexofenadine hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOLS POVIDONES TITANIUM DIOXIDE FERRIC OXIDE RED peach 93;7253"],"spl_unclassified_section":["Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 180 mg 30 71610-041-30 90 71610-041-60 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20180222DKJ Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["<table border=\"0\" cellpadding=\"1\" cellspacing=\"1\" width=\"28%\"> <colgroup> <col width=\"10%\"/> <col/> </colgroup> <tbody> <tr styleCode=\"Toprule\"> <td valign=\"bottom\" align=\"center\" styleCode=\"bold\">Count</td> <td valign=\"bottom\" align=\"center\"> <content styleCode=\"bold\">180 mg</content> </td> </tr> <tr> <td valign=\"bottom\" align=\"center\">30</td> <td align=\"center\">71610-041-30</td> </tr> <tr> <td valign=\"bottom\" align=\"center\">90</td> <td align=\"center\">71610-041-60</td> </tr> </tbody> </table>"],"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 • do not use if printed foil under cap is broken or missing • store at 20°-25°C (68°-77°F) • protect from excessive moisture • this product meets the requirements of USP Dissolution Test 3"],"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 right away. (1-800-222-1222)"],"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)"]}