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. 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
Loratadine 10mg
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. You may report side effects to 1-888-952-0050.
ask a health professional before use.
In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.
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
croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69168-309-08 | 2020-03-13 | C162847 | 48780-1 | 9d75b9d0-1d1d-f424-e053-dadaa90a57ce | 309 - Health A2Z Allergy Relief |
| 69168-309-09 | 2020-03-13 | C162847 | 48780-1 | 9d75b9d0-1d1d-f424-e053-dadaa90a57ce | 309 - Health A2Z Allergy Relief |
| 69168-309-10 | 2020-03-13 | C162847 | 48780-1 | 9d75b9d0-1d1d-f424-e053-dadaa90a57ce | 309 - Health A2Z Allergy Relief |
| 69168-309-30 | 2020-03-13 | C162847 | 48780-1 | 9d75b9d0-1d1d-f424-e053-dadaa90a57ce | 309 - Health A2Z Allergy Relief |
| 69168-309-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1d1d-f424-e053-dadaa90a57ce | 309 - Health A2Z Allergy Relief |
| 69168-309-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1d1d-f424-e053-dadaa90a57ce | 309 - Health A2Z Allergy Relief |
| 69168-309-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1d1d-f424-e053-dadaa90a57ce | 309 - Health A2Z Allergy Relief |
| 69168-309-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1d1d-f424-e053-dadaa90a57ce | 309 - Health A2Z Allergy Relief |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69168-309-03 | Allergy Relief | 30 in 1 BLISTER PACK | TABLET | 30 | 6 | |
| 69168-309-08 | Allergy Relief | 5 in 1 BLISTER PACK | TABLET | 5 | 6 | |
| 69168-309-08 | Allergy Relief | 1 in 1 CARTON | TABLET | 1 | 6 | |
| 69168-309-09 | Allergy Relief | 10 in 1 BLISTER PACK | TABLET | 10 | 6 | |
| 69168-309-09 | Allergy Relief | 1 in 1 CARTON | TABLET | 1 | 6 | |
| 69168-309-10 | Allergy Relief | 1000 in 1 BOTTLE | TABLET | 1000 | 6 | |
| 69168-309-30 | Allergy Relief | 1 in 1 CARTON | TABLET | 1 | 6 | |
| 69168-309-30 | Allergy Relief | 30 in 1 BOTTLE | TABLET | 30 | 6 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | 1 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69168-309 | 69168-309-08, 69168-309-09, 69168-309-30, 69168-309-10, 69168-309-03 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LORATADINE | 7AJO3BO7QN | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | 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 | TABLET / ORAL | 4384 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 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 |
|---|---|---|---|---|---|---|---|
| A076471-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 |
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 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 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 |
|---|---|---|---|---|---|---|
| Allergy Relief | LORATADINE | Allegiant Health | 0991388a-2eb8-4913-9efc-adf411eddf3a | 2018-11-08 | Warnings | 69168-309-30 69168-309-10 69168-309-09 69168-309-08 69168-309-03 69168-309 69168030910 69168030909 69168030930 69168030908 69168030903 520a7a7c-a1a5-48a6-b472-9d47a4463452 0991388a-2eb8-4913-9efc-adf411eddf3a |
Adverse event summaries are temporarily unavailable. Other product information remains available.