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 65 YEARS OF AGE AND OLDER ASK A DOCTOR ADULTS AND CHILDREN 12-64 YEARS OF AGE take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms CHILDREN 6-11 YEARS OF AGE take ½ tablet (2.5 mg) once daily in the evening do not take more than ½ tablet (2.5 mg) in 24 hours CHILDREN UNDER 6 ...
store between 20-25°C (68-77°F) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
LEVOCETIRIZINE DIHYDROCHLORIDE USP 5 MG
Antihistamine
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Do not use
Ask a doctor before use if you have
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding:
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 65 YEARS OF AGE AND OLDER
ADULTS AND CHILDREN 12-64 YEARS OF AGE
CHILDREN 6-11 YEARS OF AGE
CHILDREN UNDER 6 YEARS OF AGE
CONSUMERS WITH KIDNEY DISEASE
colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
CALL 1-866-933-6337
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 36cf9111-9cc4-8f59-a74c-0c1cfbd4a760 | Product name | 7 | 20190702 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73581-201 | 73581-201-80, 73581-201-10, 73581-201-18, 73581-201-36 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2025-12-03 | full-release | 2026-06-01 01:19:26 |
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 |
|---|---|---|---|---|---|---|---|
| A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 |
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 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A213513-001 | LEVOCETIRIZINE DIHYDROCHLORIDE | 5MG | TABLET / ORAL | 2020-04-29 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| 450fca8a-7ac1-d5fc-e063-6394a90aec36 | 8ee69332-742d-4071-95df-84bc42e170e7 | 2025-12-03 | Warnings | 8ee69332-742d-4071-95df-84bc42e170e7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.