Indications and uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
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
safety sealed: do not use if carton is opened or if inner safety seal is torn or missing store between 20° to 25°C (68° to 77°F) protect from excessive moisture
Drug Facts
Fexofenadine HCl, USP 180 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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.
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 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 (1-800-222-1222).
| 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 |
croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized maize starch, titanium dioxide
Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.
Distributed By:
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428
NDC 46122-779-66
Compare to
Allegra® Allergy
active ingredient*
GOOD
NEIGHBOR
PHARMACY®
NON-DROWSY
Fexofenadine
Hydrochloride
Tablets, USP
180 mg
Antihistamine
Indoor & Outdoor Allergies
Allergy
24 Hours
Relief of:
90 Tablets

| Class | Version | Type | Effective |
|---|---|---|---|
| FEXOFENADINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 46122-779-58 | FEXOFENADINE HYDROCHLORIDE | 5 in 1 BLISTER PACK | TABLET, FILM COATED | 5 | 1 | |
| 46122-779-58 | FEXOFENADINE HYDROCHLORIDE | 3 in 1 CARTON | TABLET, FILM COATED | 3 | 1 | |
| 46122-779-61 | FEXOFENADINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 | |
| 46122-779-61 | FEXOFENADINE HYDROCHLORIDE | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 | |
| 46122-779-66 | FEXOFENADINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 1 | |
| 46122-779-66 | FEXOFENADINE HYDROCHLORIDE | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 46122-779-58 | EA - Each | 46122-779 | 929ecaf9-eec9-46e8-8ef7-3c83c1f2f820 | 1 | 2025-02-10 |
| 46122-779-61 | EA - Each | 46122-779 | 2d01b6b2-2bb0-4c43-9390-451a48560a3d | 1 | 2025-02-10 |
| 46122-779-66 | EA - Each | 46122-779 | e4775287-7bc1-43df-8ccd-ce865728dd7c | 1 | 2025-02-10 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 46122-779 | 46122-779-61, 46122-779-66, 46122-779-58 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FEXOFENADINE HYDROCHLORIDE | 2S068B75ZU | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2012-02-06 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | AMERISOURCE BERGEN | 2a578643-adc1-44ca-83f2-9d48527bd3a4 | 2024-05-14 | Warnings | 46122-779-58 46122-779-61 46122-779-66 46122-779 46122077966 46122077961 46122077958 76ea7e25-e968-4c78-9eca-ac960ad55985 2a578643-adc1-44ca-83f2-9d48527bd3a4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.