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
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
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
safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing store between 2°C and 30°C (36°F and 86°F) protect from excessive moisture
Drug Facts
Loratadine 10 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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.
| 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 |
colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose
Call 1-800-706-5575, weekdays, 8:30 am - 5:00 pm Eastern Standard Time
| Manufactured by: | Manufactured for: |
| Apotex Inc. | Apotex Corp. |
| Toronto, Ontario | Weston, Florida |
| Canada M9L 1T9 | 33326 |
Revised: August 2018
APOTEX CORP. NDC 60505-0147-1
Loratadine Tablets 10 mg
Non-Drowsy*
Antihistamine/Original Prescription Strength
†Compare to the active ingredient in Claritin® Tablets
Indoor & Outdoor Allergies
24 hour
Relief of
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60505-0147-1 | Loratadine | 100 in 1 BOTTLE | TABLET | 100 | 9 | |
| 60505-0147-8 | Loratadine | 1000 in 1 BOTTLE | TABLET | 1000 | 9 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-0147-1 | EA - Each | 60505-0147 | 2f6b8572-500d-439c-a606-f85bf0d6d322 | 1 | 2012-07-24 |
| 60505-0147-8 | EA - Each | 60505-0147 | dcd03106-7da8-440e-bc01-15c5d4af430f | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LORATADINE | ACTIVE INGREDIENT | 7AJO3BO7QN | 1 | |
| LORATADINE | ACTIVE MOIETY | 7AJO3BO7QN | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 60505-0147 | 60505-0147-1, 60505-0147-8 |
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 |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, COATED / ORAL | 300 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / BUCCAL | 43 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE / ORAL | 8946 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE / ORAL | 257 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 690 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / SUBCUTANEOUS | 98 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | WAFER / ORAL | 66 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED / ORAL | 968 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 144 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 150 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, EXTENDED RELEASE / ORAL | 2575 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 520 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FILM COATED / ORAL | 330 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE, FOR SUSPENSION / ORAL | 282 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 107 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | POWDER, FOR SUSPENSION / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | PELLET / ORAL | 162 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 214 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| 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 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 | A076471-001 | LORATADINE | 10MG | TABLET / ORAL | 2006-02-14 | c2088c7a36db… | ||
| 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… |
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 |
|---|---|---|---|---|---|---|
| c15c5b51-bc6a-e99e-e5e7-52e61c5da7b0 | 679164cc-7505-7ed4-13fe-87f06cb777d8 | 2025-09-22 | Warnings | c15c5b51-bc6a-e99e-e5e7-52e61c5da7b0 679164cc-7505-7ed4-13fe-87f06cb777d8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.