{ "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": 9 } }, "results": [ { "spl_product_data_elements": [ "Fexofenadine HCl and Pseudoephedrine HCI Fexofenadine HCl and Pseudoephedrine HCI FEXOFENADINE HYDROCHLORIDE FEXOFENADINE MANNITOL PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE POWDERED CELLULOSE STARCH, CORN CROSCARMELLOSE SODIUM SILICON DIOXIDE FERRIC OXIDE RED MAGNESIUM STEARATE Hypromelloses TRIETHYL CITRATE R;195 off white to pale yellow one layer and light red to red other layer carton30count" ], "active_ingredient": [ "Active ingredient(s) Fexofenadine HCl USP, 60 mg Pseudoephedrine HCl USP,120 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 nasal congestion itchy, watery eyes itching of the nose or throat 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 takeas 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 Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contacta 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 takeas 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": [ "Pregnancy/Breastfeeding 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 contacta 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
" ], "spl_unclassified_section": [ "Other information safety sealed: do not use if carton is opened or if individual blister units are torn or opened this product meets the requirements of USP dissolution test 3." ], "storage_and_handling": [ "Storage store between 20° to 25°C (68° to 77°F)" ], "inactive_ingredient": [ "Inactive ingredients corn starch, croscarmellose sodium, colloidal silicon dioxide, ferric oxide, hypromellose, kollidon SR, magnesium stearate, mannitol, powder cellulose, and triethyl citrate." ], "questions": [ "Questions or comments? call toll-free 1-888-375-3784 Manufactured by: Dr. Reddy’s Laboratories Limited Bachupally - 500 090 INDIA" ], "package_label_principal_display_panel": [ "Principal Display Panel Blister carton 30's (6x5 unit-dose)" ], "set_id": "0de7fc37-7f46-4e98-d5ac-d31a3c313a62", "id": "8c74b0a5-6bbc-0f8d-bbda-46d6cb39aea6", "effective_time": "20171207", "version": "3", "openfda": { "application_number": [ "ANDA076667" ], "brand_name": [ "Fexofenadine HCl and Pseudoephedrine HCI" ], "generic_name": [ "FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI" ], "manufacturer_name": [ "HEB" ], "product_ndc": [ "37808-022" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FEXOFENADINE HYDROCHLORIDE", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "rxcui": [ "997406" ], "spl_id": [ "8c74b0a5-6bbc-0f8d-bbda-46d6cb39aea6" ], "spl_set_id": [ "0de7fc37-7f46-4e98-d5ac-d31a3c313a62" ], "package_ndc": [ "37808-022-31" ], "original_packager_product_ndc": [ "55111-447" ], "unii": [ "2S068B75ZU", "6V9V2RYJ8N" ] } } ] }