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
Claritin
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2025-12-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:19:40
Label at a glance#
ProductClaritin Allergy
Active ingredientLORATADINE
Label structure14 sections
Dosage and administration
use only with enclosed dosing cup mL = milliliter Adults and children 6 years and over: 10 mL 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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each 5 mL teaspoonful)
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
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.
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
- use only with enclosed dosing cup
- mL = milliliter
Adults and children 6 years and over: 10 mL 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
Other Information
- each 5 mL contains: sodium 5.5 mg
- do not use if tape imprinted with “SEALED FOR YOUR PROTECTION” on top and bottom flaps of carton is not intact.
- store between 20° and 25°C (68° and 77°F)
INACTIVE INGREDIENT SECTION
edetate disodium, flavors, glycerin, maltitol, menthol, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium phosphate, sorbitol, sucralose
Questions or comments?
1-800-CLARITIN (1-800-252-7484)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 755476 | Claritin Children's 5 MG in 5 mL Oral Solution | PSN | 2 |
| 692783 | loratadine 5 MG in 5 mL Oral Solution | PSN | 2 |
| 755476 | loratadine 1 MG/ML Oral Solution [Claritin] | SBD | 2 |
| 692783 | loratadine 1 MG/ML Oral Solution | SCD | 2 |
| 755476 | Claritin 1 MG/ML Oral Solution | SY | 2 |
| 755476 | Claritin 5 MG per 5 ML Oral Solution | SY | 2 |
| 755476 | Claritin Children's 5 MG per 5 ML Oral Solution | SY | 2 |
| 692783 | loratadine 5 MG per 5 ML Oral Solution | SY | 2 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0041100595416 | GTIN-13: 0041100595416 EAN-13: 0041100595416 GTIN-12: 041100595416 UPC-A: 041100595416 GTIN storage (14 digits): 00041100595416 | Claritin Liquid Cooling Honey Carton.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11523-0101-1 | ClaritinAllergy | 30 mL in 1 BOTTLE | SOLUTION | 30 | 2 | |
| 11523-0101-1 | ClaritinAllergy | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 11523-0101-2 | ClaritinAllergy | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 11523-0101-2 | ClaritinAllergy | 80 mL in 1 BOTTLE | SOLUTION | 80 | 2 | |
| 11523-0101-3 | ClaritinAllergy | 240 mL in 1 BOTTLE | SOLUTION | 240 | 2 | |
| 11523-0101-3 | ClaritinAllergy | 1 in 1 CARTON | SOLUTION | 1 | 2 |
Products#
Every source-derived product name is available through these pages.
- Claritin Allergy
- loratadine
- EDETATE DISODIUM
- SORBITOL
- MALTITOL
- GLYCERIN
- PHOSPHORIC ACID
- SUCRALOSE
- WATER
- SODIUM PHOSPHATE, MONOBASIC
- PROPYLENE GLYCOL
- SODIUM BENZOATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11523-0101 | 11523-0101-1, 11523-0101-2, 11523-0101-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| SORBITOL | 506T60A25R | IACT |
| MALTITOL | D65DG142WK | IACT |
| LORATADINE | 7AJO3BO7QN | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM PHOSPHATE, MONOBASIC | 3980JIH2SW | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
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 |
|---|---|---|---|---|---|---|---|
| N020641-002 | CLARITIN | LORATADINE | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | |
| N020641-003 | CLARITIN HIVES RELIEF | LORATADINE | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 |
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 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020641-002 | CLARITIN | 1MG/ML | SYRUP / ORAL | RLD, RS | 2002-11-27 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020641-003 | CLARITIN HIVES RELIEF | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP / ORAL | RLD | 2003-11-19 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Claritin Allergy | LORATADINE | Bayer HealthCare LLC. | 19afd658-8c67-af44-e063-6394a90abada | 2025-12-04 | Warnings | 11523-0101-1 11523-0101-2 11523-0101-3 11523-0101 11523010102 11523010103 11523010101 4526da60-c33b-fb4a-e063-6294a90a8692 19afd658-8c67-af44-e063-6394a90abada |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.