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 Oral Solution USP 5 mg/5 mL
- Manufacturer
- BluePoint Laboratories | Aurobindo Pharma Limited
- Effective date
- 2025-05-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:11
Label at a glance#
ProductLoratadine
Active ingredientLORATADINE
Label structure15 sections
Dosage and administration
use only with enclosed dosing cup mL= milliliter adults and children 6 years and over 10mL daily; do not take more than 10mL in 24 hours children 2 to under 6 years of age 5mL daily; do not take more than 5mL in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Storage and handling
each 5mLcontains : sodium 6 mg do not use if carton is opened, or if cap safety seal is broken or missing. store at 20° to 25°C (68° to 77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient (in each 5 mL)
Loratadine USP 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
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 (1-800-222-1222) right away.
Directions
- use only with enclosed dosing cup
- mL= milliliter
| adults and children 6 years and over | 10mL daily; do not take more than 10mL in 24 hours |
| children 2 to under 6 years of age | 5mL daily; do not take more than 5mL in 24 hours |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other information
- each 5mLcontains: sodium 6 mg
- do not use if carton is opened, or if cap safety seal is broken or missing.
- store at 20° to 25°C (68° to 77°F)
Inactive ingredients
artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.
Questions or comments?
Call 1-855-274-4122
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India
For BluePoint Laboratories
Code:TS/DRUGS/19/1993
Revised: 04/2025
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle)
Ages
2 years
and older
Loratadine
Oral Solution USP
5 mg/5 mL
Antihistamine
Non-Drowsy*
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Do not use if carton is opened,
or if cap safety seal is broken
or missing.
- Dye-Free
- Sugar-Free
- Alcohol Free
Indoor & Outdoor Allergies
Contains sodium metabisulfite,
a sulfite that may cause
allergic-type reactions.
* When taken as directed. See Drug Facts Panel.
Grape Flavor
4FL OZ (120 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL)
#Compare to the
active ingredient in
children’s Claritin®
Ages
2years
and older
Loratadine
Oral Solution USP
5 mg/5 mL
Antihistamine
Non-Drowsy*
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy,watery Eyes
- Itchy Throat or Nose
Indoor & Outdoor Allergies
Dosing Cup Included
- Dye-Free
- Sugar-Free
- Alcohol Free
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.
* When taken as directed.
See Drug Facts Panel.
Grape
Flavor
4 FL OZ (120 mL)
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68001-449-98 | Loratadine | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 68001-449-98 | Loratadine | 120 mL in 1 BOTTLE | SOLUTION | 120 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68001-449-98 | ML - Milliliter | 68001-449 | cf6ac655-1561-43e9-83e6-1779c94b3337 | 1 | 2020-09-14 |
Products#
Every source-derived product name is available through these pages.
- Loratadine
- Loratadine Oral
- GRAPE
- ASCORBIC ACID
- GLYCERIN
- MALTITOL
- SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
- PHOSPHORIC ACID
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SODIUM METABISULFITE
- SORBITOL
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68001-449 | 68001-449-98 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GRAPE | 6X543N684K | IACT |
| ASCORBIC ACID | PQ6CK8PD0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MALTITOL | D65DG142WK | IACT |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM METABISULFITE | 4VON5FNS3C | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | 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 |
|---|---|---|---|---|---|---|---|
| A208931-001 | LORATADINE | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 |
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 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A208931-001 | LORATADINE | 1MG/ML | SYRUP / ORAL | 2018-06-29 | 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 |
|---|---|---|---|---|---|---|
| Loratadine | LORATADINE ORAL | BluePoint Laboratories | ab820f80-b5fc-7896-e053-2995a90a4b1c | 2025-05-15 | Warnings | 68001-449-98 68001-449 68001044998 352cf9e6-9f6c-b81e-e063-6394a90a397f ab820f80-b5fc-7896-e053-2995a90a4b1c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.