Loratadine 10mg Tablets
- Manufacturer
- AMZ789 LLC
- Effective date
- 2025-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:51:37
Label at a glance#
ProductLORATADINE
Active ingredientLORATADINE
Label structure7 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Loratadine 10mg
OTC - PURPOSE SECTION
Antihistamine
WARNINGS SECTION
OTC - DO NOT USE SECTION
Do not use if you have ever had an allergic reaction to this product or any of its ingredients
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
OTC - WHEN USING SECTION
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
OTC - STOP USE SECTION
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.
INDICATIONS & USAGE SECTION
DOSAGE & ADMINISTRATION SECTION
Adults and children 6 years and over 1 tablet daily: no 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
SAFE HANDLING WARNING SECTION
Other Information ● store between 20-25°C (68-77°F) ● protect from excessive moisture ● do not use if imprinted seal under safety cap is broken or missing
INACTIVE INGREDIENT SECTION
Inactive Ingredients lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73629-003-18 | LORATADINE | 180 in 1 BOTTLE | TABLET | 180 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- LORATADINE
- MAGNESIUM STEARATE
- SODIUM STARCH GLYCOLATE TYPE A
- LACTOSE MONOHYDRATE
- ANHYDROUS LACTOSE
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73629-003 | 73629-003-18 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
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 | AMZ789 LLC | db71197e-d633-644d-e053-2a95a90a261d | 2025-01-08 | Warnings | 73629-003-18 73629-003 73629000318 2b3b13e2-8085-77d5-e063-6394a90a0a58 db71197e-d633-644d-e053-2a95a90a261d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.