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 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 ifyou 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 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 (1-800-222-1222) right away.
| 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, pregelatinized starch (maize), sodium starch glycolate
call 1-800-630-8895
NDC 80513-711-03
Compare to the Active Ingredient in Claritin ®*
Loratadine 10 mg
Allergy Relief
Non-Drowsy**
Antihistamine
24 Hour Relief of:
Original Prescription Strength
**When Taken as Directed. See Drug Facts Panel.
300 Tablets
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED
*This product is not manufactured or distributed by the owner of the registered trademark Claritin ®
Distributed by:
ADVANCED RX LLC,
1942 NE 163rd St
North Miami Beach,
FL 33162 U.S.A.

| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80513-711-01 | Loratadine | 100 in 1 BOTTLE | TABLET | 100 | 3 | |
| 80513-711-03 | Loratadine | 300 in 1 BOTTLE | TABLET | 300 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 80513-711 | 80513-711-03, 80513-711-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | 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 |
|---|---|---|---|---|---|---|---|
| A210722-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 |
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 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 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 |
|---|---|---|---|---|---|---|
| Loratadine | LORATADINE | Advanced Rx LLC | e96b4671-82dc-4cc6-a8bf-ef6f1efd8a7d | 2025-02-25 | Warnings | 80513-711-01 80513-711-03 80513-711 80513071101 80513071103 2efad4c4-593e-fa4d-e063-6294a90a0ebc e96b4671-82dc-4cc6-a8bf-ef6f1efd8a7d |
Adverse event summaries are temporarily unavailable. Other product information remains available.