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
• do not use if blister unit is broken or torn. • store between 20 ° to 25 ° C (68 ° to 77 ° F) • protect from excessive moisture
Loratadine 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.
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. (1-800-222-1222)
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, povidone, pregelatinized starch
1-800-432-6111
Allergy Relief
Compare to the active ingredient in Claritin® Tablets
Loratadine Tablets, 10 mg
Antihistamine
Original Prescription Strength
INDOOR & OUTDOOR ALLERGIES
Non-Drowsy*
24 Hour
Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat & Nose
10 TABLETS
Actual Size
*When taken as directed. See Drug Facts Panel.


| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69256-612-46 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8f9e-d83d-e063-dadaa90ab31f | Harris Teeter, LLC Allergy Relief Drug Facts |
| 69256-612-65 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8f9e-d83d-e063-dadaa90ab31f | Harris Teeter, LLC Allergy Relief Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | 1 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69256-612 | 69256-612-46, 69256-612-65 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LORATADINE | 7AJO3BO7QN | ACTIB |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | 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 |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 214 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 107 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 750 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 9.5 %w/v | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FOR SUSPENSION / ORAL | 2794 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, EXTENDED RELEASE / ORAL | 101 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INSERT / VAGINAL | 2282 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, COATED / ORAL | 1301 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 214 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, ORALLY DISINTEGRATING / ORAL | 366 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / SUBLINGUAL | 505 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 690 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, DELAYED RELEASE / ORAL | 2313 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION / AURICULAR (OTIC) | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CREAM / VAGINAL | 586 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TROCHE / ORAL | 30 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED / ORAL | 968 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | PELLET / ORAL | 640 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED PELLETS / ORAL | 265 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / INTRAMUSCULAR | 150 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER, FOR SUSPENSION / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 47.5 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 150 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 |
|---|---|---|---|---|---|---|---|
| A076301-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2004-06-25 |
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 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 |
|---|---|---|---|---|---|---|
| 4140d8f7-b622-4c38-b15d-36408059a989 | a3bedebd-1fcc-44a1-a889-239c30600de5 | 2025-10-13 | Warnings | a3bedebd-1fcc-44a1-a889-239c30600de5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.