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
Loratadine
- Manufacturer
- GRANULES USA, INC.
- Effective date
- 2025-12-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:59
Label at a glance#
ProductLoratadine
Active ingredientLORATADINE
Label structure14 sections
Dosage and administration
■adults and children6 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Loratadine 10 mg
Purpose
Antihistamine
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
Do not use
if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you have
liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product
do not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor 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 overdose, get medical help or contact a Poison Control Center right away.
Directions
■adults and children6 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
Other information
■ Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
■ store between 20° to 25°C (68° to 77°F)
Inactive ingredients
lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized.
Questions?
contact 1-877-770-3183: Mon-Fri 8:00AM EST to 5:00PM PST
PDP
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0813874020032 | GTIN-13: 0813874020032 EAN-13: 0813874020032 GTIN-12: 813874020032 UPC-A: 813874020032 GTIN storage (14 digits): 00813874020032 | 200000003488_R-00_Final.jpg |
| Data code | Data Matrix | 200000003488 | 200000003488_R-00_Final.jpg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69848-019-10 | Loratadine | 100 in 1 BOTTLE | TABLET | 100 | 5 |
Products#
Every source-derived product name is available through these pages.
- Loratadine
- MAGNESIUM STEARATE
- LACTOSE MONOHYDRATE
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69848-019 | 69848-019-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| 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 Orange Book product history#
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 cross-check#
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 | GRANULES USA, INC. | c3c9bc45-7ed5-abf4-e053-2995a90a40ff | 2025-12-22 | Warnings | 69848-019-10 69848-019 69848001910 469099a1-3de4-d107-e063-6294a90adf16 c3c9bc45-7ed5-abf4-e053-2995a90a40ff |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.