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 Syrup
- Manufacturer
- Rebel Distributors Corp
- Effective date
- 2011-02-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:27:19
Label at a glance#
ProductLoratadine
Active ingredientLoratadine
Label structure10 sections
Dosage and administration
adults and children 6 years and over 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours children 2 to under 6 years of age 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours consumers with liver or kidney disease ask a doctor
Storage and handling
safety sealed: do not use if imprinted safety seal is torn or missing store between 2° and 25°C (36° and 77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 5 mL)
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.
Stop use and ask a doctor if
- an allergic reaction to this product occurs. Seek medical help right away.
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
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
| adults and children 6 years and over | 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours |
| children 2 to under 6 years of age | 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours |
| consumers with liver or kidney disease | ask a doctor |
Other information
- safety sealed: do not use if imprinted safety seal is torn or missing
- store between 2° and 25°C (36° and 77°F)
Inactive ingredients
artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose
SPL UNCLASSIFIED SECTION
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
PRINCIPAL DISPLAY PANEL - 4 FL OZ Label
(Loratadine
Oral Solution)
5 mg/5mL Antihistamine
4 FL OZ (120 mL)
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-498-04 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49f8-48b1-e053-8cdaa90a720a | Loratadine Syrup |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-498-04 | Loratadine | 120 mL in 1 BOTTLE | SOLUTION | 120 | 1 | |
| 21695-498-04 | Loratadine | 1 in 1 CARTON | SOLUTION | 1 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-498-04 | ML - Milliliter | 21695-498 | a4ee976a-4886-47dd-adef-b43f0c2d55aa | 1 | 2012-07-24 |
| 51672-2073-8 | ML - Milliliter | 51672-2073 | 8d48a532-2118-4d9a-bd23-7f5e5e5d50d1 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Loratadine | ACTIVE INGREDIENT | 7AJO3BO7QN | 1 | |
| Loratadine | ACTIVE MOIETY | 7AJO3BO7QN | 1 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| sodium metabisulfite | INACTIVE INGREDIENT | 4VON5FNS3C | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Loratadine
- citric acid monohydrate
- glycerin
- propylene glycol
- water
- sodium benzoate
- sodium metabisulfite
- sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 21695-498 | 21695-498-04 |
| 51672-2073 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Loratadine | 7AJO3BO7QN | ACTIB |
| citric acid monohydrate | 2968PHW8QP | IACT |
| glycerin | PDC6A3C0OX | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| water | 059QF0KO0R | IACT |
| sodium benzoate | OJ245FE5EU | IACT |
| sodium metabisulfite | 4VON5FNS3C | IACT |
| sucrose | C151H8M554 | IACT |
Source Document#
Inactive ingredient matches#
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 |
|---|---|---|---|---|---|---|
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| sodium metabisulfite | SODIUM METABISULFITE | 4VON5FNS3C | SOLUTION / ORAL | 640 mg |
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 |
|---|---|---|---|---|---|---|---|
| A076805-001 | LORATADINE | LORATADINE | 1MG/ML | SYRUP / ORAL | 2004-08-20 |
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 | 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 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 |
|---|---|---|---|---|---|---|
| Childrens Loratadine | LORATADINE | Sun Pharmaceutical Industries, Inc. | 78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0 | 2026-04-08 | Warnings | 51672-2073 |
| 32f9efb1-3ab9-4d3c-a3b3-fd94874bea98 | 32f9efb1-3ab9-4d3c-a3b3-fd94874bea98 | 2011-02-23 | Warnings | 32f9efb1-3ab9-4d3c-a3b3-fd94874bea98 32f9efb1-3ab9-4d3c-a3b3-fd94874bea98 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.