adults and children 12 years of age and over take one 180 mg tablet with water once a day; 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
Fexofenadine HCl USP, 180 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
if you have ever had an allergic reaction to this product or any of its ingredients.
kidney disease. Your doctor should determine if you need a different dose.
an allergic reaction to this product occurs. Seek medical help right away.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
| adults and children 12 years of age and over | take one 180 mg tablet with water once a day; 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 |
colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Red no. 40, hypromellose, iron oxide black, magnesium stearate, mannitol, polyethylene glycol, powder cellulose and titanium dioxide
Call 1-888-375-3784
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-5191-3 | 2022-02-07 | C162847 | 48780-1 | d6a99b39-bbbf-a426-e053-dadaa90af4c2 | Fexofenadine HCl Tablets USP |
| 68071-5191-3 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-bbbf-a426-e053-dadaa90af4c2 | Fexofenadine HCl Tablets USP |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55111-784-01 | EA - Each | 55111-784 | fcfbe779-dfaf-4c1a-b197-12b0a5ca5247 | 1 | 2018-12-13 |
| 55111-784-30 | EA - Each | 55111-784 | 9ca6ce31-a274-408f-b03e-0b74b74bc4fd | 1 | 2015-09-10 |
| Product NDC | Package NDC |
|---|---|
| 68071-5191 | 68071-5191-3 |
| 55111-784 |
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076502-001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2006-04-11 | ||
| A076502-002 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2006-04-11 | ||
| A076502-003 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2006-04-11 | ||
| A076502-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-007 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2011-04-12 | ||
| A076502-009 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2011-04-12 |
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1b56d919-6d42-428a-e063-6294a90a0fa9 | a00eca6b-2d4e-7d32-e053-2995a90aaaaf | 2024-06-20 | Warnings |
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use 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 doctor if an allergic reaction to this product occurs. Seek medical help right away. 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.