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
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
adults and children 6 years and over 2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours children 2 to under 6 years of age 1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful)(TSP))
Purpose: Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
ever had allergic reaction to this product or any of it's ingredients Do not use if you have
liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor before use if you have
do not take more than directed. Taking more than directed may cause drowsiness. When using this product
an allergic reaction to this product occurs. Seek medical help right away. Stop use and ask a doctor if
, ask a health professional before use. If pregnant or breast-feeding
. In case of overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children
| adults and children 6 years and over
| 2 teaspoonfuls (TSP) daily; do not take more than 2 teaspoonfuls (TSP) in 24 hours
|
| children 2 to under 6 years of age
| 1 teaspoonful (TSP) daily; do not take more than 1 teaspoonful (TSP) in 24 hours
|
| children under 2 years of age
| ask a doctor
|
| consumers with liver or kidney disease
| ask a doctor
|
Butylated hydroxylanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.
1-800-616-2471
Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150 USA
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Data code | Code 128 | 17856623405 | 17856-6234.jpg |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-6234-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-27ba-f424-e053-dadaa90a57ce | Children's Loratadine Oral Solution |
| 17856-6234-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-27ba-f424-e053-dadaa90a57ce | Children's Loratadine Oral Solution |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-6234-2 | Loratadine | 5 mL in 1 CUP | SOLUTION | 5 | 3 | |
| 17856-6234-5 | Loratadine | 5 mL in 1 CUP | SOLUTION | 5 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-6234 | LORATADINE (LORATADINE) SOLUTION [ATLANTIC BIOLOGICALS CORPS] | 3 | Legacy NDC, 2 package rows | 20160816_5a443fa3-a38f-4e4e-b6a0-7773a3d5ec83.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6234-20 | ML - Milliliter | 0904-6234 | ec603472-48db-4d13-b80b-603f857bff1d | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 17856-6234 | 17856-6234-2, 17856-6234-5 |
| 0904-6234 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Loratadine | 7AJO3BO7QN | ACTIB |
| anhydrous citric acid | XF417D3PSL | IACT |
| butylated hydroxyanisole | REK4960K2U | IACT |
| glycerin | PDC6A3C0OX | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| sodium benzoate | OJ245FE5EU | IACT |
| sucralose | 96K6UQ3ZD4 | IACT |
| water | 059QF0KO0R | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A077421-001 | LORATADINE | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 |
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 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A077421-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| ccf9ac38-566e-4fe2-86c7-0b62b52153fc | 5a443fa3-a38f-4e4e-b6a0-7773a3d5ec83 | 2016-08-16 | Warnings | ccf9ac38-566e-4fe2-86c7-0b62b52153fc 5a443fa3-a38f-4e4e-b6a0-7773a3d5ec83 |
Adverse event summaries are temporarily unavailable. Other product information remains available.