Indications and uses
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
FEXOFENADINE HYDROCHLORIDE TABLETS
- Manufacturer
- RETAIL BUSINESS SERVICES, LLC
- Effective date
- 2020-09-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:29:40
Label at a glance#
ProductFEXOFENADINE HYDROCHLORIDE
Active ingredientFEXOFENADINE HYDROCHLORIDE
Label structure14 sections
Dosage and administration
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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Fexofenadine HCl 180 mg
Purpose
Antihistamine
Uses
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
OTC - DO NOT USE SECTION
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a
different dose.
OTC - WHEN USING SECTION
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)
OTC - STOP USE SECTION
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek
medical help right away. You may report side effects to FDA at
1-800-FDA-1088.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
| 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 |
OTHER SAFETY INFORMATION
Other information safety sealed: do not use if printed foil inner
seal on bottle is torn or missing store between 20º and 25ºC (68º
and 77ºF) protect from excessive moisture
INACTIVE INGREDIENT SECTION
Inactive ingredients colloidal silicone dioxide, croscarmellose sodium, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol/macrogol, povidone, pregelatinized starch, red iron oxide,
silica, titanium dioxide, yellow iron oxide.
OTC - QUESTIONS SECTION
Questions or comments? call +1-888-333-9792
PRINCIPAL DISPLAY PANEL
non-drowsy
FEXOFENADINE
HYDROCHLORIDE
TABLETS USP
180 mg
antihistamine
24 Hour
indoor & outdoor allergy relief
• sneezing • runny nose
• itchy, watery eyes
• itchy nose or throat
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| FEXOFENADINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72476-121-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-e250-a426-e053-dadaa90af4c2 | FEXOFENADINE HYDROCHLORIDE TABLETS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72476-121-30 | FEXOFENADINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 72476-121-30 | FEXOFENADINE HYDROCHLORIDE | 1 in 1 CARTON | TABLET | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- FEXOFENADINE HYDROCHLORIDE
- FERRIC OXIDE YELLOW
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- HYPROMELLOSE 2910 (15 MPA.S)
- HYPROMELLOSE 2910 (5 MPA.S)
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL 400
- POVIDONE
- STARCH, CORN
- FERRIC OXIDE RED
- TITANIUM DIOXIDE
- FEXOFENADINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72476-121 | 72476-121-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2018-08-13 |
Observed Orange Book product history#
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 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2018-08-13 | f41ea6bd6efb… |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| af8425e2-7318-88b7-e053-2995a90a3c1f | af8425e2-7317-88b7-e053-2995a90a3c1f | 2020-09-17 | Warnings | af8425e2-7318-88b7-e053-2995a90a3c1f af8425e2-7317-88b7-e053-2995a90a3c1f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.