CAREALL Loratadine
- Manufacturer
- New World Imports
- Effective date
- 2025-12-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:45:05
Label at a glance#
ProductCAREALL Loratadine
Active ingredientLORATADINE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Loratadine 10mg
OTC - PURPOSE SECTION
Antihistamine
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
INDICATIONS & USAGE SECTION
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose, itchy, watery eys, sneezing, itching of the nose or throat
WARNINGS SECTION
Do not useif you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before useif you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this productdo not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctorif an allergic reaction to this product occurs. Seek medical help right away.
DOSAGE & ADMINISTRATION SECTION
Adult and children over 6 years old:1 tablets 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
INACTIVE INGREDIENT SECTION
lactose monohydrate, magnesium stearate, sodium starch glycolate. May contain: microcrystalline cellulose, pregelatinized starch
OTHER SAFETY INFORMATION
Store between 20-25 degrees celcius (68-77 degrees farhenheit).
Protect from excessive moisture
Do not use if imprinted seal under bottle cap is broken or missing
You may report side effects 1-888-952-0050
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0085317008413 | GTIN-13: 0085317008413 EAN-13: 0085317008413 GTIN-12: 085317008413 UPC-A: 085317008413 GTIN storage (14 digits): 00085317008413 | Loratadine Label.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51824-075-01 | EA - Each | 51824-075 | 2488c274-518d-4141-8d04-2b8d0ecfb571 | 1 | 2021-08-05 |
Products#
Every source-derived product name is available through these pages.
- CAREALL Loratadine
- Loratadine
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- LACTOSE MONOHYDRATE
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51824-075 | 51824-075-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210722-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 |
Observed Orange Book product history#
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 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210722-001 | LORATADINE | 10MG | TABLET / ORAL | 2019-12-23 | a50c72e98297… |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 44ebd856-8544-77d1-e063-6394a90a2b86 | 4d952d2f-7766-4e64-8462-3fdff144546a | 2025-12-01 | Warnings | 44ebd856-8544-77d1-e063-6394a90a2b86 4d952d2f-7766-4e64-8462-3fdff144546a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.