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
use only with enclosed dosing cup 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
do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing. see bottom panel for lot number and expiration date store between 20° and 25°C (68° and 77°F)
Drug Facts
Loratadine 5 mg
Antihistamine
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Do not useif you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.
When using this productdo not take more than directed. Taking more than directed may cause drowsiness.
Stop use and ask a doctor ifan 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. (1-800-222-1222)
| 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 hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.
DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811
1-888-267-3037
NDC 56062-132-08
AGES 2 YEARS
AND OLDER
INDOOR & OUTDOOR
ALLERGIES
children's
allergy
LORATADINE ORAL
SOLUTION USP, 5 mg/5 mL
ALLERGY
ANTIHISTAMINE
Non-drowsy*
24-hour relief of:
GRAPE FLAVOR
DOSING CUP
INCLUDED
DYE FREE
SUGAR FREE
*When taken as directed. See Drug Facts Panel.
4 FL OZ (120 mL)
†Compare to
the Active Ingredient
in Children's Claritin
®

| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 56062-132-08 | 2025-07-29 | C162847 | 48780-1 | 3b156c62-2ac8-fb37-e063-e6dba90a4e07 | ee208bad-a70e-4882-8b82-e9f00e31be31 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 56062-132-08 | childrens allergySugar Free | 120 mL in 1 BOTTLE | SOLUTION | 120 | 3 | |
| 56062-132-08 | childrens allergySugar Free | 1 in 1 CARTON | SOLUTION | 1 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 56062-132 | 56062-132-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BUTYLATED HYDROXYANISOLE | REK4960K2U | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE | 5QWK665956 | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
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 |
|---|---|---|---|---|---|---|---|
| A076805-001 | LORATADINE | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 |
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 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076805-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 | 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 |
|---|---|---|---|---|---|---|
| 29a433bc-a83b-ffc7-e063-6294a90a465a | ee208bad-a70e-4882-8b82-e9f00e31be31 | 2024-12-19 | Warnings | 29a433bc-a83b-ffc7-e063-6294a90a465a ee208bad-a70e-4882-8b82-e9f00e31be31 |
Adverse event summaries are temporarily unavailable. Other product information remains available.