Fexofenadine
Fexofenadine is an FDA drug label for the active ingredient FEXOFENADINE manufactured by YYBA Corp administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260727.
- Generic name
- FEXOFENADINE
- Manufacturer
- YYBA Corp
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 73581-012
- Application
- ANDA219032
- Label effective
- 20260727
About this product
Fexofenadine is an FDA-registered drug product whose active ingredient is FEXOFENADINE. It is labelled by YYBA Corp taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 73581-012, application ANDA219032, label effective 20260727. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing FEXOFENADINE are most often described in connection with: temporarily relieves, symptoms due, hay fever, respiratory allergies, runny nose, sneezing itchy, watery eyes. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Dosage & Administration
Directions adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; 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
Warnings
Warnings Do not use if you ever had an allergic reaction to this product or any of its ingredients Ask a doctor before using 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 healthcare professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0654-2026 | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30 | SUN PHARMACEUTICAL INDUSTRIES INC | Class III | Ongoing | 20260708 |
| D-0273-2024 | Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India. | SUN PHARMACEUTICAL INDUSTRIES INC | Class II | Completed | 20240131 |
| D-0912-2023 | Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count cartons (NDC 36800-691-95), and 90-count cartons (NDC 36800-691-75), Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007. | L. Perrigo Company | Class II | Terminated | 20230719 |
| D-0909-2023 | allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811. | L. Perrigo Company | Class II | Terminated | 20230719 |
| D-0910-2023 | allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons (NDC 11673-617-39), c)70-count cartons (NDC 11673-617-01), and d)150-count cartons (11673-617-47), Distributed by: Target Corporation, Minneapolis, MN 55403. | L. Perrigo Company | Class II | Terminated | 20230719 |
Frequently asked questions
What is Fexofenadine used for?
Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Who makes Fexofenadine?
YYBA Corp is the labeler of record for Fexofenadine.
What form does Fexofenadine come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Fexofenadine prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Fexofenadine been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.