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 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours Children under 6 years of age: ask a doctor Consumers with liver or kidney disease: ask a doctor
Loratadine 10mg
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
liver or kidney disease. Your doctor should determine if you need a different dose.
do not take more than directed. Taking more than directed may cause drowsiness.
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 accidental overdose, contact a doctor or Poison Control Center immediately.
Adults and children 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours
Children under 6 years of age: ask a doctor
Consumers with liver or kidney disease: ask a doctor
lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53117-407 | 53117-407-85 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LORATADINE | 7AJO3BO7QN | ACTIB |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | 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 |
|---|---|---|---|---|---|---|---|
| A076471-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 |
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 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 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 |
|---|---|---|---|---|---|---|
| acb8f014-82e0-4758-8779-621a1c36002b | f47f9973-90e3-463c-a4a4-e7b925462089 | 2019-09-20 | Warnings | f47f9973-90e3-463c-a4a4-e7b925462089 |
Adverse event summaries are temporarily unavailable. Other product information remains available.