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 Orally Disintegrating Tablets USP
- Manufacturer
- Tenshi Kaizen Pvt Ltd
- Effective date
- 2024-01-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:06:21
Label at a glance#
ProductLoratadine
Active ingredientLORATADINE
Label structure11 sections
Dosage and administration
place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Storage and handling
safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally disintegrating Tablet, USP is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Loratadine 5 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
Warnings
OTC - DO NOT USE SECTION
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
OTC - WHEN USING SECTION
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
OTC - STOP USE SECTION
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
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
- place 1 tablet on tongue; tablet disintegrates, with or without water
| adults and children 6 years and over | 1 tablet every 12 hours; not more than 2 tablets in 24 hours |
| children under 6 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other information
- safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally disintegrating Tablet, USP is open or torn
- store between 20° to 25°C (68° to 77°F)
- use tablet immediately after opening individual blister
- complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
Inactive ingredients
anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan
Questions or comments?
1-877-244-9825 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day.
SPL UNCLASSIFIED SECTION
Manufactured by:
Tenshi Kaizen Private Limited
Bengaluru Rural – 562112, India
Revised: 01/2023
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72983-500-01 | Loratadine | 1 in 1 CARTON | TABLET | 1 | 5 | |
| 72983-500-01 | Loratadine | 10 in 1 BLISTER PACK | TABLET | 10 | 5 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Loratadine
- ANHYDROUS CITRIC ACID
- PULLULAN
- POLYSORBATE 80
- MANNITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72983-500 | 72983-500-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| PULLULAN | 8ZQ0AYU1TT | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| MANNITOL | 3OWL53L36A | 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 |
|---|---|---|---|---|---|---|---|
| A212795-001 | LORATADINE | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 |
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 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212795-001 | LORATADINE | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2020-09-18 | 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 |
|---|---|---|---|---|---|---|
| Loratadine | LORATADINE | Tenshi Kaizen Pvt Ltd | c20b91e0-ef92-6f2f-e053-2a95a90a2a36 | 2024-01-02 | Warnings | 72983-500-01 72983-500 72983050001 0df0dfde-1f52-4769-e063-6394a90a2f92 c20b91e0-ef92-6f2f-e053-2a95a90a2a36 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.