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
Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature] Protect from excessive moisture SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR PROTECTION" IS OPEN OR TORN
Loratadine USP, 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.
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 |
SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR PROTECTION" IS OPEN OR TORN
colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate
call 1-609-860-2600 Hours: 8am-4pm, EST.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53041-285-21 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-5077-a426-e053-dadaa90af4c2 | Guardian Loratadine Tablets |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53041-285-21 | Guardian Loratadine | 1000 in 1 BOTTLE | TABLET | 1000 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53041-285 | 53041-285-21 |
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 |
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 |
|---|---|---|---|---|---|---|---|
| A207569-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 |
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 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207569-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-03-12 | 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 |
|---|---|---|---|---|---|---|
| af8cdd37-8fd0-4651-ae03-36c7d4863301 | af8cdd37-8fd0-4651-ae03-36c7d4863301 | 2019-07-22 | Warnings | af8cdd37-8fd0-4651-ae03-36c7d4863301 af8cdd37-8fd0-4651-ae03-36c7d4863301 |
Adverse event summaries are temporarily unavailable. Other product information remains available.