Indications and uses
temporarily relieves these symptoms due to hay fever and other upper respiratory allergies: runny nose sneezing itching of the nose and throat itchy, watery eyes
Loratadine
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2026-03-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:49:12
Label at a glance#
ProductLoratadine
Active ingredientLORATADINE
Label structure8 sections
Dosage and administration
adults and children 12 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Storage and handling
TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. store between 20° to 25°C (68° to 77°F) protect from light
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Loratadine, USP 10 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose and throat
- itchy, watery eyes
Warnings
Do not use if you have ever had an allergic reaction to this
product or any of its ingredients.
Ask a doctor before use if you have liver or kidney disease.
Your doctor should determine if you need a different dose.
When using this product do not take more than directed.
Taking more than directed may cause drowsiness.
Stop use and ask a doctor if an allergic reaction to this
product occurs. Seek medical help right away.
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
| adults and children
12 years and over | 1 tablet daily; not more
than 1 tablet in 24 hours |
| children under 12
years of age | ask a doctor |
| consumers with liver
or kidney disease | ask a doctor |
Other information
- TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
- store between 20° to 25°C (68° to 77°F)
- protect from light
Inactive ingredients
lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions?
call 1-800-540-3765
package label
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0368071239232 | GTIN-13: 0368071239232 EAN-13: 0368071239232 GTIN-12: 368071239232 UPC-A: 368071239232 GTIN storage (14 digits): 00368071239232 | 68071-2392-3.jpg |
| Data code | Data Matrix | 0100368071239232210000000002<GS>170000010000000<GS> | 68071-2392-3.jpg |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-2392-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-d0e6-0266-e053-dadaa90a7c1a | 788S (658) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2392-3 | Loratadine | 30 in 1 BOTTLE | TABLET | 30 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-658-03 | EA - Each | 57896-658 | 68d4cd4a-0106-45bc-bdb5-e1c18b355e95 | 1 | 2022-03-09 |
| 57896-658-09 | EA - Each | 57896-658 | 1b15dde2-c586-4c46-a621-5729663b7fc7 | 1 | 2022-03-09 |
| 57896-658-36 | EA - Each | 57896-658 | 875757b6-7b45-4cee-a29b-2f35aa21f133 | 1 | 2024-04-05 |
Products#
Every source-derived product name is available through these pages.
- Loratadine
- SODIUM STARCH GLYCOLATE TYPE A CORN
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-2392 | 68071-2392-3 |
| 57896-658 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | 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 |
|---|---|---|---|---|---|---|---|
| A075209-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 |
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 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075209-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-01-21 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Loratadine | LORATADINE | NuCare Pharmaceuticals,Inc. | c0e3057d-2dd2-de2b-e053-2995a90a1a1d | 2026-03-05 | Warnings | 68071-2392-3 68071-2392 68071239203 4c5020ce-2905-00f7-e063-6394a90a61b2 c0e3057d-2dd2-de2b-e053-2995a90a1a1d |
| Allergy relief | LORATADINE | Geri-Care Pharmaceutical Corp | b66f171a-7b95-b27a-e053-2a95a90a6009 | 2025-07-28 | Warnings | 57896-658 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.