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 of kidney disease ask a doctor
(in each tablet)
Loratadine USP, 10 mg
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.
an allergic reaction to this product occurs. Seek medical help right away.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center 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 of kidney disease | ask a doctor |
Corn starch, lactose monohydrate and magnesium stearate.
call 1-877-446-3679 (1-877-4-INFO-RX)
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Code No.: MH/DRUGS/25/NKD/89
PRODUCT PACKAGING
NDC 0378-8880-10
Original Prescription Strength
Non-Drowsy*
Loratadine
Tablets USP, 10 mg
Antihistamine
Indoor and Outdoor Allergies
24 Hour Relief of:
*When taken as directed. See Drug Facts Panel.
RMX8880C1
100 Tablets



| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-8880-10 | Loratadine | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 6 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | 3 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0378-8880 | 0378-8880-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LORATADINE | 7AJO3BO7QN | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg |
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 |
|---|---|---|---|---|---|---|---|
| A076154-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 |
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 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 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 | LORATADINE | Mylan Pharmaceuticals Inc. | 3b307aea-5a68-4c82-959a-cda4ffbd0a4a | 2013-11-15 | Warnings | 0378-8880-10 0378-8880 00378888010 1392dd15-842c-4689-87ba-caafc0503bca 3b307aea-5a68-4c82-959a-cda4ffbd0a4a |
Adverse event summaries are temporarily unavailable. Other product information remains available.