{"active_ingredient":["Active ingredient (in each tablet) Fexofenadine hydrochloride USP"],"ask_doctor_or_pharmacist":["Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose."],"dosage_and_administration":["Directions - 60 mg (12 Hour Relief) 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 Directions - 180 mg (24 Hour Relief) 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":["
adults and children 12 years of age and overtake one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor
","
adults and children 12 years of age and overtake one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor
"],"effective_time":"20211129","id":"d1f32dc7-8a7d-e0a5-e053-2995a90a8963","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":{},"other_safety_information":["Other information TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] protect from excessive moisture"],"package_label_principal_display_panel":["Principal Display Panel – 60 mg NDC 51079-547-20 Fexofenadine HCl Tablets, USP 60 mg Antihistamine Non-Drowsy Indoor/Outdoor Allergy Relief 12 HR (See Uses section of enclosed leaflet) TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. S-11114 R4 This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Fexofenadine Hydrochloride Tablets, USP 60 mg Carton Label Outer Carton Label","Principal Display Panel – 180 mg NDC 51079-548-20 Fexofenadine HCl Tablets, USP 180 mg Antihistamine Non-Drowsy Indoor/Outdoor Allergy Relief 24 HR (See Uses section of enclosed leaflet) TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. S-11115 R3 This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Fexofenadine Hydrochloride Tablets, USP 120 mg Carton Label Outer Carton Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions? 1-800-848-0462 Serious side effects associated with use of this product may be reported to this number."],"set_id":"35e4d021-77a0-4473-aa4f-f1b23aff422f","spl_product_data_elements":["Fexofenadine Hydrochloride fexofenadine hydrochloride 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 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE M;753 Fexofenadine Hydrochloride fexofenadine hydrochloride 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 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE capsule-shaped M;755"],"spl_unclassified_section":["Non-Drowsy Indoor/Outdoor Allergy Relief TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.","HOW SUPPLIED Fexofenadine Hydrochloride Tablets, USP are available containing 60 mg or 180 mg of fexofenadine hydrochloride, USP. The 60 mg tablets are blue film-coated, round, biconvex, beveled edge, unscored tablets debossed with M over 753 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-547-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). The 180 mg tablets are blue film-coated, caplet-shaped, biconvex, beveled edge, unscored tablets debossed with M 755 on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-548-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from excessive moisture. Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-11117 R4 12/16"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"8","warnings":["Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients."],"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)"]}