Indications and uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
LORATADINE
- Manufacturer
- Apotex Corp.
- Effective date
- 2019-08-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:14:49
Label at a glance#
ProductLORATADINE
Active ingredientLORATADINE
Label structure11 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 or kidney disease ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
SPL PRODUCT DATA ELEMENTS SECTION
SPL UNCLASSIFIED SECTION
Active ingredient (in each tablet)
Loratadine, USP 10
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
Warnings
Do not use
if you have ever had an allergic reaction to thisproduct 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 or kidney disease | ask a doctor |
Other information
- store between 2° and 30°C (36° and 86°F)
- do not use if seal under bottle cap is broken or missing
- protect from excessive moisture
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose
Questions or comments?
Call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time
Principal Display Panel
Just Well NDC 60505-4649-3
Non-Drowsy*
Loratadine Tablets, USP 10 mg
Antihistamine
Indoor & Outdoor Allergies
24 hour
Relief of:
Sneezing Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Principal Display Panel
Just Well NDC 60505--4649-3
Non-Drowsy*
Loratadine Tablets, USP 10 mg
Antihistamine
Indoor & Outdoor Allergies
24 hour Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Products#
Every source-derived product name is available through these pages.
- LORATADINE
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 60505-4649 | 60505-4649-3 |
Ingredients#
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 |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A076471-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 |
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 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | 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 |
|---|---|---|---|---|---|---|
| 0bd4bb1d-84e4-4a03-03f4-865c2e1419c3 | e49f5425-9aef-798c-d215-e418e4faf8c2 | 2019-08-21 | Warnings | 0bd4bb1d-84e4-4a03-03f4-865c2e1419c3 e49f5425-9aef-798c-d215-e418e4faf8c2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.