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
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
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 180 mg
Antihistamine
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
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 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.
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.
| 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 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 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.
Questions or comments? call +1-888-333-9792
Distributed by:
Spirit Pharmaceuticals LLC,
Ronkonkoma, NY 11779
ORG 03/19
Manufactured by:
Unique Pharmaceutical
Laboratories
(A Div. of J. B. Chemicals &
Pharmaceuticals Ltd.)
Mumbai 400 030, India
Mfg. Lic. No.: G/1430
Valumeds™
NDC 68210-0122-1
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
100 tablets
Actual Size
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68210-0122-1 | 2026-01-29 | C162847 | 48780-1 | 49896155-ce8b-586f-e063-e6dba90add90 | Valumeds FEXOFENADINE HYDROCHLORIDE TABLETS USP 180 mg |
| 68210-0122-3 | 2026-01-29 | C162847 | 48780-1 | 49896155-ce8b-586f-e063-e6dba90add90 | Valumeds FEXOFENADINE HYDROCHLORIDE TABLETS USP 180 mg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-0122-1 | FEXOFENADINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | 8 | |
| 68210-0122-3 | FEXOFENADINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 8 | |
| 68210-0122-3 | FEXOFENADINE HYDROCHLORIDE | 1 in 1 CARTON | TABLET | 1 | 8 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-0122 | FEXOFENADINE HYDROCHLORIDE TABLET [SPIRIT PHARMACEUTICALS LLC] | 8 | Legacy NDC, 3 package rows | 20241215_c18f3207-92ad-4999-99c8-b51a1edcece3.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68210-0122 | 68210-0122-1, 68210-0122-3 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|---|
| A210137-001 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2018-08-13 |
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 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 |
|---|---|---|---|---|---|---|
| 292e7312-a98d-3369-e063-6394a90a0555 | c18f3207-92ad-4999-99c8-b51a1edcece3 | 2024-12-13 | Warnings | 292e7312-a98d-3369-e063-6394a90a0555 c18f3207-92ad-4999-99c8-b51a1edcece3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.