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 or kidney disease ask a doctor
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.
if 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 or kidney disease | ask a doctor |
Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
1-800-525-8747
10-2015M
Sandoz Inc.
Princeton, NJ 08540
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-5077-01 | EA - Each | 0781-5077 | ee2bd65b-3fef-4be8-badd-bf30aea9e7c9 | 1 | 2012-07-24 |
| 0781-5077-64 | EA - Each | 0781-5077 | d1533bfe-0d09-41a8-b3de-70ebebf3c12b | 1 | 2012-07-24 |
| 0781-5077-76 | EA - Each | 0781-5077 | 7f0bca63-8292-4908-b293-10884106fc88 | 1 | 2013-02-11 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | 14 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | 14 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 14 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 14 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 14 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 14 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0781-5077 | 0781-5077-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LORATADINE | 7AJO3BO7QN | ACTIB |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | 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 |
|---|---|---|---|---|---|---|
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER / RESPIRATORY (INHALATION) | 25 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED / ORAL | 300 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | 174 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, SUGAR COATED / ORAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, DELAYED RELEASE / ORAL | 2087 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 690 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE / ORAL | 8946 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CREAM / VAGINAL | 586 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / BUCCAL | 43 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED PELLETS / ORAL | 265 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / SUBCUTANEOUS | 98 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER, FOR SUSPENSION / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 214 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 214 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE / ORAL | 2169 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE, FOR SOLUTION / ORAL | 1691.8 mg/120ml | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, COATED / ORAL | 1301 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED / ORAL | 968 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 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 |
|---|---|---|---|---|---|---|---|
| A075209-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| 7b2c3c36-bf13-46b7-908c-949672ebf806 | a0593748-88fe-481f-9608-740ea6a304e7 | 2019-02-15 | Warnings | 7b2c3c36-bf13-46b7-908c-949672ebf806 a0593748-88fe-481f-9608-740ea6a304e7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.