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 Tablets, 10 mg
- Manufacturer
- Granules India Limited
- Effective date
- 2025-08-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:17:53
Label at a glance#
ProductLoratadine
Active ingredientLORATADINE
Label structure14 sections
Dosage and administration
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
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
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
WARNINGS
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 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 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 |
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 OR COMMENTS
Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62207-787-49 | Loratadine | 1000 in 1 BOTTLE | TABLET | 1000 | 5 | |
| 62207-787-88 | Loratadine | 5 in 1 BOX | TABLET | 5 | 5 | |
| 62207-787-88 | Loratadine | 20000 in 1 POUCH | TABLET | 20000 | 5 |
Products#
Every source-derived product name is available through these pages.
- Loratadine
- MAGNESIUM STEARATE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- LACTOSE MONOHYDRATE
- ANHYDROUS LACTOSE
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62207-787 | 62207-787-49, 62207-787-88 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| STARCH, CORN | O8232NY3SJ | 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 India Limited | 9bae1ba3-c0da-23a2-e053-2a95a90a58ed | 2025-08-01 | Warnings | 62207-787-49 62207-787-88 62207-787 62207078788 62207078749 3b4cd1e9-fe92-7333-e063-6294a90af3f5 9bae1ba3-c0da-23a2-e053-2a95a90a58ed |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.