{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE CELLULOSE ACETATE SILICON DIOXIDE COPOVIDONE K25-31 CROSCARMELLOSE SODIUM DIBUTYL SEBACATE FERROSOFERRIC OXIDE GLYCERYL MONO- AND DICAPRYLOCAPRATE HYPROMELLOSE 2208 (100000 MPA.S) HYPROMELLOSE 2910 (3 MPA.S) LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE 200 POLYETHYLENE GLYCOL 400 POLYVINYL ALCOHOL, UNSPECIFIED PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STEARIC ACID TALC TITANIUM DIOXIDE white to off-white biconvex with slightly blister surfaced FES" ], "active_ingredient": [ "Drug Facts Active ingredients (in each tablet) Fexofenadine Hydrochloride USP 180 mg Pseudoephedrine Hydrochloride USP 240 mg" ], "purpose": [ "Purpose Antihistamine Nasal decongestant" ], "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 temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have difficulty swallowing" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. Your doctor should determine if you need a different dose." ], "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 ) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions )." ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless If pregnant or breast-feeding, ask a health professional before use." ], "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 (1-800-222-1222) right away." ], "dosage_and_administration": [ "Directions do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 24 hours on an empty stomach; 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 Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened store between 20° and 25°C (68° and 77°F) FDA approved dissolution test specifications differ from USP" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take 1 tablet with a glass of water every 24 hours on an empty stomach; 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
" ], "inactive_ingredient": [ "Inactive ingredients cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, dibutyl sebacate, ferrosoferric oxide, glyceryl mono- and di-caprylocaprate, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, propylene glycol, shellac, sodium lauryl sulfate, stearic acid, talc and titanium dioxide Questions or Comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2026 Walgreen Co. MADE IN INDIA" ], "package_label_principal_display_panel": [ "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 5 Blister Carton Walgreens Compare to the active ingredients in Allegra-D ® 24 Hour Allergy & Congestion Tablets †† NON-DROWSY Allergy Relief D ALLERGY & CONGESTION FEXOFENADINE HYDROCHLORIDE 180 mg / ANTIHISTAMINE PSEUDOEPHEDRINE HYDROCHLORIDE 240 mg / NASAL DECONGESTION 24 Hour Extended-Release Tablets, USP Indoor/outdoor relief of: • Nasal & sinus congestion due to colds or allergies • Sneezing; runny nose; itchy, watery eyes & itchy nose or throat due to allergies 10 EXTENDED-RELEASE TABLETS ACTUAL SIZE fig1" ], "set_id": "4daddd32-615f-aedf-e063-6394a90a5b09", "id": "db9e5d0b-a865-49e7-b5c4-1fc6eb205339", "effective_time": "20260901", "version": "2", "openfda": { "application_number": [ "ANDA215232" ], "brand_name": [ "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride" ], "generic_name": [ "FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE" ], "manufacturer_name": [ "WALGREEN CO." ], "product_ndc": [ "0363-0270" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FEXOFENADINE HYDROCHLORIDE", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "rxcui": [ "997415" ], "spl_id": [ "db9e5d0b-a865-49e7-b5c4-1fc6eb205339" ], "spl_set_id": [ "4daddd32-615f-aedf-e063-6394a90a5b09" ], "package_ndc": [ "0363-0270-10" ], "is_original_packager": [ true ], "unii": [ "2S068B75ZU", "6V9V2RYJ8N" ] } } ] }