{"active_ingredient":["Active ingredient (in each film-coated 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/> <col/> <tbody> <tr> <td valign=\"top\" styleCode=\"     Botrule          Toprule         Lrule          Rrule     \"> adults and children 12 years of age and over</td> <td valign=\"top\" styleCode=\"     Botrule          Rrule     \"> take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours</td> </tr> <tr> <td valign=\"top\" styleCode=\"     Botrule         Lrule          Rrule     \"> children under 12 years of age</td> <td valign=\"top\" styleCode=\"     Botrule          Rrule     \"> do not use</td> </tr> <tr> <td valign=\"top\" styleCode=\"     Botrule         Lrule          Rrule     \"> adults 65 years of age and older</td> <td valign=\"top\" styleCode=\"     Botrule          Rrule     \"> ask a doctor</td> </tr> <tr> <td valign=\"top\" styleCode=\"     Botrule         Lrule          Rrule     \"> consumers with kidney disease</td> <td valign=\"top\" styleCode=\"     Botrule          Rrule     \"> ask a doctor</td> </tr> </tbody> </table>"],"effective_time":"20200604","id":"2efc7b8c-7917-4b6c-815b-7a13c0c80338","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 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 - 180 mg NDC 71610-429 - Fexofenadine HCl, USP 180 mg Tablets Bottle Label 180 mg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call: 1-800-616-2471"],"set_id":"2a59f3cd-4c11-4fc4-ac77-c6a2af12ce9e","spl_product_data_elements":["Fexofenadine Hydrochloride Fexofenadine HCl FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW ANHYDROUS LACTOSE STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED LACTOSE MONOHYDRATE STEARIC ACID TITANIUM DIOXIDE SG;202"],"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 71610-429-30 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 20200527JH 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\">71610-429-30</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 each tablet contain : sodium 8 mg store between 20 to 25°C (68 to 77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 2"],"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)"]}