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
Loratadine - Safecor Health, LLC
- Manufacturer
- Safecor Health, LLC
- Effective date
- 2026-03-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:52:10
Label at a glance#
ProductLoratadine
Active ingredientLORATADINE
Label structure14 sections
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 of kidney disease ask a doctor
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 or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
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.
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 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 of kidney disease | ask a doctor |
Other information
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. - Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
- protect from excessive moisture
Inactive ingredients
Corn starch, lactose monohydrate and magnesium stearate.
Questions or comments?
call 1-800-447-1006
- Serious side effects associated with use of this product may be reported to this number.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Code No.: MH/DRUGS/25/NKD/89
Distributed by:
Safecor Health LLC
Rockford, IL 61103 U.S.A.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRODUCT PACKAGING
NDC 48433-064-20
Loratadine
Tablets USP, 10 mg
Antihistamine
Original Prescription StrengthNon-Drowsy*
Indoor and Outdoor Allergies
24 Hour Relief(See Uses section of Patient Information)
*When taken as directed. See Patient Information.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48433-064-01 | Loratadine | 1 in 1 BLISTER PACK | TABLET | 1 | 2 | |
| 48433-064-20 | Loratadine | 100 in 1 CARTON | TABLET | 100 | 2 |
Products#
Every source-derived product name is available through these pages.
- Loratadine
- STARCH, CORN
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48433-064 | 48433-064-01, 48433-064-20 |
| 0378-8880 |
Ingredients#
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 |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-03-25 | monthly-update | 2026-06-03 17:59:00 |
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 |
|---|---|---|---|---|---|---|---|
| A076154-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076154-001 | LORATADINE | 10MG | TABLET / ORAL | 2003-08-20 | 3a93d1ddd44b… |
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 | Safecor Health, LLC | 14d1ecf5-d694-4ce0-87e4-df27f3f4d909 | 2026-03-31 | Warnings | 48433-064-20 48433-064-01 48433-064 48433006401 48433006420 4e5410fd-6d27-f0d2-e063-6394a90a016f 14d1ecf5-d694-4ce0-87e4-df27f3f4d909 |
| Loratadine | LORATADINE | Mylan Pharmaceuticals Inc. | 3b307aea-5a68-4c82-959a-cda4ffbd0a4a | 2013-11-15 | Warnings | 0378-8880 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.