{"active_ingredient":["Active ingredient (in each tablet) Fexofenadine HCl USP, 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 border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"0\"><colgroup><col width=\"\"/><col width=\"\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\">adults and children 12 years of age and over</td><td styleCode=\"Rrule\" valign=\"middle\">take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\">children under 12 years of age</td><td styleCode=\"Rrule\" valign=\"middle\">do not use</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\">adults 65 years of age and older</td><td styleCode=\"Rrule\" valign=\"middle\">ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"middle\">consumers with kidney disease</td><td styleCode=\"Rrule\" valign=\"middle\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20240808","id":"1d43d4d6-9021-eac7-e063-6294a90ad21a","inactive_ingredient":["Inactive ingredients ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, 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."],"openfda":{"application_number":["ANDA211075"],"brand_name":["Fexofenadine Hydrochloride"],"generic_name":["FEXOFENADINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Granules India Limited"],"package_ndc":["62207-623-71","62207-623-41","62207-623-57","62207-623-45"],"product_ndc":["62207-623"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["997420"],"spl_id":["1d43d4d6-9021-eac7-e063-6294a90ad21a"],"spl_set_id":["1d46555d-827b-b154-e063-6294a90ad3d5"],"substance_name":["FEXOFENADINE HYDROCHLORIDE"],"unii":["2S068B75ZU"],"upc":["0362207623414","0362207623711"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 180 mg - 24s Container Label NDC 62207-623-41 NON-DROWSY Fexofenadine HCl Tablets USP, 180 mg Allergy Antihistamine INDOOR / OUTDOOR ALLERGY RELIEF 24HR Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat 24 GELCAPS Gel Coated Tablets *Compare to the active ingredient in Allegra ® Allergy 24 HOUR fexo-container-label","PRINCIPAL DISPLAY PANEL 180 mg -24s Container Carton NDC 62207-623-41 NON-DROWSY Fexofenadine HCl Tablets, USP 180 mg Allergy Antihistamine INDOOR / OUTDOOR ALLERGY RELIEF 24 HR Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat 24 GELCAPS Gel Coated Tablets *Compare to the active ingredient in Allegra ® Allergy 24 HOUR fexo-container-carton","PRINCIPAL DISPLAY PANEL 180 mg - Blister Carton NDC 62207-623-71 NON-DROWSY Fexofenadine HCl Tablets USP, 180 mg Allergy Antihistamine INDOOR / OUTDOOR ALLERGY RELIEF 24 HR Sneezing Runny Nose Itchy, Watery Eyes Itchy Nose or Throat 70 (7x10) GELCAPS Gel Coated Tablets *Compare to the active ingredient in ALLEGRA ® ALLERGY 24 HOUR fexo-blister-carton","PRINCIPAL DISPLAY PANEL 180 mg - Blister Foil NDC 62207-623-71 Fexofenadine HCl Tablet USP, 180 mg Allergy Antihistamine (GELCAP) Mfg. by: Granules India Limited Made in India M.L.No.: 37/RR/AP/2003/F/R 24 HR Push tablet through foil LOT# EXP. DATE: fexo-blister foil"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST. Manufactured By: Granules India Limited Hyderabad-500 081, India MADE IN INDIA Distributed By: Granules USA, Inc. Parsippany, NJ 07054"],"recent_major_changes":[""],"set_id":"1d46555d-827b-b154-e063-6294a90ad3d5","spl_product_data_elements":["Fexofenadine Hydrochloride Fexofenadine Hydrochloride PROPYLENE GLYCOL GELATIN HYDROXYPROPYL CELLULOSE (90000 WAMW) CROSCARMELLOSE SODIUM FERROSOFERRIC OXIDE FD&C BLUE NO. 1 FD&C YELLOW NO. 6 HYPROMELLOSE 2910 (3 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 8000 SILICON DIOXIDE STARCH, CORN TITANIUM DIOXIDE FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SHELLAC D&C RED NO. 33 AMMONIA WHITE BAND IN THE MIDDLE capsule shaped G18"],"spl_unclassified_section":["Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened store between 20º and 25ºC (68º and 77ºF) protect from excessive moisture"],"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."]}