Dosage and administration
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
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
Active ingredient (in each tablet)
Loratadine USP, 10 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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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.
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 |
Bottles:
Blisters packs:
corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch
Repackaged By: Preferred Pharmaceuticals Inc.
Call 1-888-588-1418
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 235 | loratadine-tablets-10mg-30s-carton.jpg | |
| Data code | Data Matrix | **072325* | loratadine-tablets-10mg-30s-carton.jpg |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8605-0 | EA - Each | 68788-8605 | 4070bd29-6d7a-42a7-969c-22a4b0a38337 | 1 | 2024-05-16 |
| 68788-8605-1 | EA - Each | 68788-8605 | 2954ff62-0a91-4e28-a0d7-8991f13807ef | 1 | 2024-05-16 |
| 68788-8605-3 | EA - Each | 68788-8605 | 8800d074-47ad-4891-b9a7-06d7c1810607 | 1 | 2024-05-16 |
| 68788-8605-5 | EA - Each | 68788-8605 | 549aa5fa-8c50-47b0-b872-5d65ac6589c8 | 1 | 2024-05-16 |
| 68788-8605-9 | EA - Each | 68788-8605 | 2574982f-5494-4158-8795-59e74d4e6658 | 1 | 2024-05-16 |
| 69230-323-30 | EA - Each | 69230-323 | 201bb70e-fb9b-4500-b71b-0f6a81ae4496 | 1 | 2024-04-05 |
| 69230-323-33 | EA - Each | 69230-323 | 09fff6b2-e4ce-4023-a5aa-e9130a7fc067 | 1 | 2024-04-05 |
| 69230-323-34 | EA - Each | 69230-323 | 6fb9ba44-5272-4816-918a-5e1b0ef886c1 | 1 | 2024-04-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68788-8605 | 68788-8605-0, 68788-8605-1, 68788-8605-5, 68788-8605-3, 68788-8605-9 |
| 69230-323 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-07-23 | full-release | 2026-06-01 01:08:29 |
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 |
|---|---|---|---|---|---|---|---|
| A211718-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 |
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 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 9b2671bbb829… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | a50c72e98297… |
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 | Preferred Pharmaceuticals Inc. | d778c4d2-184a-4dc8-9351-66d81d0618f2 | 2026-05-28 | Warnings | 68788-8605-3 68788-8605-9 68788-8605-1 68788-8605-0 68788-8605-5 68788-8605 68788860500 68788860503 68788860509 68788860505 68788860501 48cbeb9b-de13-4330-97b2-f87fb7e26cb9 d778c4d2-184a-4dc8-9351-66d81d0618f2 |
| Loratadine | LORATADINE | Camber Consumer Care Inc | d57da4bd-af37-414a-a50c-e80d2bb28314 | 2023-09-08 | Warnings | 69230-323 |
Adverse event summaries are temporarily unavailable. Other product information remains available.