LORATADINE
- Manufacturer
- DirectRx
- Effective date
- 2023-09-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:26:16
Label at a glance#
ProductLORATADINE
Active ingredientLORATADINE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Loratadine 10 mg
OTC - PURPOSE SECTION
Antihistamine
WARNINGS SECTION
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. (1-800-222-1222)
OTHER SAFETY INFORMATION
•
do not use if printed foil under cap is broken or missing
•
store between 20° to 25°C (68° to 77°F)
INACTIVE INGREDIENT SECTION
lactose monohydrate, magnesium stearate, povidone, pregelatinized starch
OTC - QUESTIONS SECTION
1-800-719-9260
DOSAGE & ADMINISTRATION SECTION
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
do not use if printed foil under cap is broken or missing
store at 20°-25°C (68°-77°F)
Questions or comments?
1-800-719-9260
INDICATIONS & USAGE SECTION
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-142-07 | EA - Each | 61919-142 | 98a59087-af56-4cdb-83d7-0bfd2d5b964f | 1 | 2021-10-08 |
| 61919-142-10 | EA - Each | 61919-142 | 253cc570-fd57-4996-b8a6-a84ce2ddd494 | 1 | 2015-10-02 |
| 61919-142-30 | EA - Each | 61919-142 | d2d0a0fd-f6ae-4c6f-a0c4-806a73cefde5 | 1 | 2014-05-02 |
| 61919-142-90 | EA - Each | 61919-142 | 51b4c613-a58c-4d0b-9ff5-fb0eb1e436b1 | 1 | 2015-11-12 |
| 45802-650-65 | EA - Each | 45802-650 | 2be54e45-0384-4ce9-95be-a3d9c2d051b9 | 1 | 2012-07-24 |
| 45802-650-78 | EA - Each | 45802-650 | 9595d39f-57b3-4c72-a349-5e7bf613881b | 1 | 2012-07-24 |
| 45802-650-87 | EA - Each | 45802-650 | a7cf4204-74e4-4e42-b2ff-961de1024e5e | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- LORATADINE
- MAGNESIUM STEARATE
- LACTOSE MONOHYDRATE
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61919-142 | 61919-142-07 |
| 45802-650 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| POVIDONE | FZ989GH94E | 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 |
|---|---|---|---|---|---|---|---|
| A076301-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 |
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 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076301-001 | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 | f41ea6bd6efb… |
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 antihistamine | LORATADINE | Padagis Israel Pharmaceuticals Ltd | c72d8a30-520e-4d25-8f02-0c891e070a1a | 2025-09-12 | Warnings | 45802-650 |
| 089fb769-85e3-7cbc-e063-6294a90ab5af | cbe44cc5-d534-4d17-e053-2995a90a021c | 2023-10-26 | Warnings | cbe44cc5-d534-4d17-e053-2995a90a021c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.