{"active_ingredient":["Active ingredient (in each tablet) Fexofenadine hydrochloride USP, 60 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 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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":["
adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets 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
"],"effective_time":"20171201","id":"3b6da186-33ef-4a85-90df-f008a31ab498","inactive_ingredient":["Inactive ingredients Butylated hydroxyanisole, crospovidone, FD&C Blue No. 1 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, polysorbate 80, povidone, sodium lauryl sulfate, titanium dioxide and triacetin."],"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 right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 180mg NDC 43353-760 - Fexofenadine HCl 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? Call 1-877-446-3679 (1-877-4-INFO-RX) Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Marketed/ Packaged by: GSMS, Inc., Camarillo, CA 93012 USA"],"set_id":"d0a79081-71e0-407d-876b-f4393fd4d1e5","spl_product_data_elements":["Fexofenadine Hydrochloride fexofenadine FEXOFENADINE HYDROCHLORIDE FEXOFENADINE BUTYLATED HYDROXYANISOLE CROSPOVIDONE (15 MPA.S AT 5%) FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POVIDONE, UNSPECIFIED SODIUM LAURYL SULFATE TITANIUM DIOXIDE TRIACETIN caplet-shaped M;755"],"spl_unclassified_section":["Other information • Tamper Evident: do not use if foil seal under cap is missing, open or broken • store between 20° to 25°C (68° to 77°F) • protect from excessive moisture","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 43353-760-30 60 43353-760-53 90 XXXXX-XXX-60 120 XXXXX-XXX-70 180 XXXXX-XXX-80 240 XXXXX-XXX-90 270 XXXXX-XXX-92 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 20171201JH Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["
Count 180 mg
30 43353-760-30
60 43353-760-53
90 XXXXX-XXX-60
120 XXXXX-XXX-70
180 XXXXX-XXX-80
240 XXXXX-XXX-90
270 XXXXX-XXX-92
"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"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."],"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)"]}