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
Children's Loratadine Oral Solution
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2021-02-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:50:12
Label at a glance#
ProductLoratadine
Active ingredientLORATADINE
Label structure9 sections
Dosage and administration
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
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful)(TSP))
OTC - PURPOSE SECTION
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
Do not use if you have ever had allergic reaction to this product or any of it's 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
| 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
|
Other information
- Each teaspoonful contains: sodium 1 mg
- Safety Sealed. Do not use if imprinted seal around cap is broken or missing
- Store between 20° to 25°C (68° to 77°F)
Inactive ingredients
Butylated hydroxylanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.
Questions
1-800-616-2471
Distributed by:
Major Pharmaceuticals
31778 Enterprise Drive,
Livonia, MI 48150 USA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4121-4 | 2024-10-08 | C162847 | 48780-1 | ba0f9c33-4116-a910-e053-dadaa90a0b85 | Children's Loratadine Oral Solution |
| 68071-4121-4 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4116-a910-e053-dadaa90a0b85 | Children's Loratadine Oral Solution |
| 68071-4121-1 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-4116-a910-e053-dadaa90a0b85 | Children's Loratadine Oral Solution |
| 68071-4121-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4116-a910-e053-dadaa90a0b85 | Children's Loratadine Oral Solution |
DailyMed Billing Units#
| 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 |
Products#
Every source-derived product name is available through these pages.
- Loratadine
- ANHYDROUS CITRIC ACID
- BUTYLATED HYDROXYANISOLE
- GLYCERIN
- PROPYLENE GLYCOL
- SODIUM BENZOATE
- SUCRALOSE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-4121 | 68071-4121-4 |
| 0904-6234 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| 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 |
| 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 |
|---|---|---|---|---|---|---|---|
| A077421-001 | LORATADINE | LORATADINE | 1MG/ML | SYRUP / ORAL | 2006-06-29 |
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 | 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 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 |
|---|---|---|---|---|---|---|
| 1a155a54-009d-b38f-e063-6394a90aa00a | 5bac0030-943d-c841-e053-2a91aa0afde4 | 2024-06-04 | Warnings | 5bac0030-943d-c841-e053-2a91aa0afde4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.