{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 139 } }, "results": [ { "spl_product_data_elements": [ "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride FEXOFENADINE HYDROCHLORIDE FEXOFENADINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM POVIDONE K30 MAGNESIUM STEARATE DIBASIC CALCIUM PHOSPHATE DIHYDRATE SILICON DIOXIDE ETHYLCELLULOSE, UNSPECIFIED FERRIC OXIDE YELLOW STEARIC ACID HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED bilayer 724" ], "active_ingredient": [ "Active ingredient(s) (in each extended-release tablet) Fexofenadine HCl, USP 60 mg Pseudoephedrine HCl, USP 120 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": [ "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)" ], "stop_use": [ "Stop use and ask 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" ], "pregnancy_or_breast_feeding": [ "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 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 12 hours on an empty stomach; 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 1 tablet with a glass of water every 12 hours on an empty stomach; 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
" ], "storage_and_handling": [ "Other information safety sealed; do not use if inner safety seal is open or torn store between 20° to 25°C (68° to 77°F) USP dissolution test is pending." ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethyl cellulose, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid." ], "spl_unclassified_section": [ "Questions? Call toll free 1-800-818-4555 weekdays", "Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 60 mg/120 mg Tablet Blister Pack Carton CVSHealth ™ Compare to the active ingredients in Allegra-D ® * Indoor & Outdoor Allergies Original Prescription Strength ALLERGY & CONGESTION RELIEF Allergy Relief D FEXOFENADINE HCl 60 mg/Antihistamine PSEUDOEPHEDRINE HCl 120 mg/Nasal decongestant EXTENDED RELEASE TABLETS, USP 12 HOUR 12 Hour Relief of: Nasal & sinus congestion due to colds or allergies Sneezing; Runny nose; Itchy, watery eyes & Itchy nose or throat due to allergies DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN Non-Drowsy 20 EXTENDED-RELEASE TABLETS Actual Size Principal Display Panel - 60 mg/120 mg Tablet Blister Pack Carton" ], "set_id": "02476e5a-0463-4223-8dc5-8bbe787d38dc", "id": "f6c3f3ab-f5b1-40d1-8ca9-51f55b9c66a9", "effective_time": "20180531", "version": "1", "openfda": { "application_number": [ "ANDA090818" ], "brand_name": [ "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride" ], "generic_name": [ "FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE" ], "manufacturer_name": [ "CVS Pharmacy" ], "product_ndc": [ "69842-990" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FEXOFENADINE HYDROCHLORIDE", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "rxcui": [ "997406" ], "spl_id": [ "f6c3f3ab-f5b1-40d1-8ca9-51f55b9c66a9" ], "spl_set_id": [ "02476e5a-0463-4223-8dc5-8bbe787d38dc" ], "package_ndc": [ "69842-990-20", "69842-990-30" ], "is_original_packager": [ true ], "unii": [ "2S068B75ZU", "6V9V2RYJ8N" ] } } ] }