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
store between 20° to 25° C (68° to 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Drug Facts
Loratadine, USP 10 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Do not useif you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.
When using this productdo not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor ifan 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 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 |
corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
Manufactured for/ Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev. 10/22 SP
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-7508-4 | Loratadine Allergy Relief | 90 in 1 BOTTLE | TABLET | 90 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-7508 | LORATADINE ALLERGY RELIEF (LORATADINE) TABLET [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 1 package rows | 20250223_0be70365-57ee-4f2e-a30f-bdd5c292992d.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-7508-4 | EA - Each | 50090-7508 | 5217fa26-ffad-4bdb-bf9c-88f0d07abf70 | 1 | 2025-03-04 |
| 10135-763-03 | EA - Each | 10135-763 | 76665c6a-5ac2-40b1-80ff-22c45b0cde22 | 1 | 2022-11-07 |
| 10135-763-30 | EA - Each | 10135-763 | 2dfb202a-eb54-432c-9f08-82a4f9b760c9 | 1 | 2022-11-07 |
| 10135-763-90 | EA - Each | 10135-763 | 3dd4b12f-6fb4-452c-b70e-cd3ba9f834b5 | 1 | 2022-11-07 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50090-7508 | 50090-7508-4 |
| 10135-763 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ZEA MAYS (CORN) STARCH | O8232NY3SJ | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A076134-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 |
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 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076134-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-18 | 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 |
|---|---|---|---|---|---|---|
| Loratadine Allergy Relief | LORATADINE | Marlex Pharmaceuticals, Inc. | ec08a6ee-3d71-0fa9-e053-2995a90a9cb1 | 2025-11-18 | Warnings | 10135-763 |
| Loratadine Allergy Relief | LORATADINE | A-S Medication Solutions | 0be70365-57ee-4f2e-a30f-bdd5c292992d | 2025-02-20 | Warnings | 50090-7508-4 50090-7508 50090750804 49bbeae9-aed2-4189-a3a7-e1598667beb8 0be70365-57ee-4f2e-a30f-bdd5c292992d |
Adverse event summaries are temporarily unavailable. Other product information remains available.