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
Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken store at 20°C to 25°C (68° to 77°F) protect from excessive moisture
Loratadine USP 10 mg
Antihistamine
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
Do not use
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.
an allergic reaction to this product occurs. Seek medical help right away.
ask a health professional before use.
In case of an 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
Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
store at 20°C to 25°C (68° to 77°F)
protect from excessive moisture
lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.
call 1-855-274-4122
Manufactured by: Aurobindo Pharma Limited
Hyderabad-509 302,
INDIA
For BluePoint Laboratories
MADE IN INDIA
Code: TS/DRUGS/22/2009
Issued: 04/2020
Repackaged By: Preferred Pharmaceuticals Inc.
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8628 | LORATADINE TABLET [PREFERRED PHARMACEUTICALS INC.] | 1 | Unmatched | 20240420_f0d2874f-e60e-4b48-a5c3-db02c34df336.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8628-0 | EA - Each | 68788-8628 | 860b9cd7-0f63-4d29-b494-ae8cbdcf3bb9 | 1 | 2024-06-10 |
| 68788-8628-1 | EA - Each | 68788-8628 | 54948ae7-2a18-4c59-8b52-9a8930c450a9 | 1 | 2024-06-10 |
| 68788-8628-3 | EA - Each | 68788-8628 | d96c1384-34b0-4528-934a-292110770ccb | 1 | 2024-06-10 |
| 68788-8628-5 | EA - Each | 68788-8628 | ab70acfe-f0be-4992-8e06-f73e0d58a6a4 | 1 | 2024-06-10 |
| 68788-8628-9 | EA - Each | 68788-8628 | 3570640a-6360-4f0d-9dba-8b697746040b | 1 | 2024-06-10 |
| 68001-438-00 | EA - Each | 68001-438 | 6e74c3de-ea3f-483e-a42b-5ba0d1ae4ef1 | 1 | 2020-09-14 |
| 68001-438-04 | EA - Each | 68001-438 | 41f66523-e262-4daa-926f-fbe68195d8f2 | 1 | 2020-09-14 |
| 68001-438-16 | EA - Each | 68001-438 | 5f258780-6f3a-4623-9621-33adbc7b8583 | 1 | 2020-09-14 |
| 68001-438-96 | EA - Each | 68001-438 | 64e6b8ad-162b-4047-afb1-9d7c3730db11 | 1 | 2020-09-14 |
| 68001-438-97 | EA - Each | 68001-438 | 1ef363df-9d7d-4b65-906b-d6d48f569b85 | 1 | 2020-09-14 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68788-8628 | 68788-8628-0, 68788-8628-1, 68788-8628-5, 68788-8628-3, 68788-8628-9 |
| 68001-438 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | 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 |
|---|---|---|---|---|---|---|---|
| A208314-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 |
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 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A208314-001 | LORATADINE | 10MG | TABLET / ORAL | 2018-04-16 | 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 |
|---|---|---|---|---|---|---|
| 8f73d69d-8e75-4842-b071-53d45d414f19 | f0d2874f-e60e-4b48-a5c3-db02c34df336 | 2025-07-23 | Warnings | f0d2874f-e60e-4b48-a5c3-db02c34df336 | ||
| Loratadine | LORATADINE | BluePoint Laboratories | adc506ed-7a7a-facc-e053-2a95a90ae147 | 2022-06-20 | Warnings | 68001-438 |
Adverse event summaries are temporarily unavailable. Other product information remains available.