{ "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": "2026-08-11", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "spl_product_data_elements": [ "Fexofenadine HCl and Pseudoephedrine HCl Fexofenadine HCl and Pseudoephedrine HCl FEXOFENADINE HYDROCHLORIDE FEXOFENADINE ACETONE CROSCARMELLOSE SODIUM CELLULOSE ACETATE COPOVIDONE HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE Polyethylene Glycol, Unspecified TALC TITANIUM DIOXIDE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE ISOPROPYL ALCOHOL FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE WATER SODIUM CHLORIDE FERRIC OXIDE RED POVIDONE K30 FERROSOFERRIC OXIDE PROPYLENE GLYCOL SILICON DIOXIDE 892 carton" ], "active_ingredient": [ "Active ingredient(s) Fexofenadine HCl USP, 180 mg Pseudoephedrine HCl USP, 240 mg" ], "purpose": [ "Purpose Antihistamine Nasal decongestant" ], "indications_and_usage": [ "Use(s) 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 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 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 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 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." ], "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) 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 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 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" ], "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 agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor
" ], "spl_unclassified_section": [ "Other information each tablet contains: 28 mg sodium safety sealed: do not use if carton is opened or if individual blister units are torn or opened store between 20° - 25°C (68° - 77°F) FDA approved dissolution test specifications differ from USP" ], "inactive_ingredient": [ "Inactive ingredients acetone, black iron oxide, cellulose acetate, colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, red iron oxide, sodium chloride, talc, titanium dioxide, water" ], "questions": [ "Questions? Questions? Call 1-888-375-3784 Weekdays (9am - 8pm EST) Distributed by: Dr. Reddy’s Laboratories, Inc. Princeton, NJ 08540" ], "package_label_principal_display_panel": [ "" ], "set_id": "3a878985-3a0e-1960-db0e-e3b8fd9d5c63", "id": "132629da-7f70-439b-3df7-876d0aeb01ee", "effective_time": "20260310", "version": "5", "openfda": { "application_number": [ "ANDA079043" ], "brand_name": [ "Fexofenadine HCl and Pseudoephedrine HCl" ], "generic_name": [ "FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL" ], "manufacturer_name": [ "CVS Pharmacy, Inc" ], "product_ndc": [ "51316-018" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FEXOFENADINE HYDROCHLORIDE", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "rxcui": [ "997415" ], "spl_id": [ "132629da-7f70-439b-3df7-876d0aeb01ee" ], "spl_set_id": [ "3a878985-3a0e-1960-db0e-e3b8fd9d5c63" ], "package_ndc": [ "51316-018-10", "51316-018-15" ], "is_original_packager": [ true ], "unii": [ "2S068B75ZU", "6V9V2RYJ8N" ] } } ] }