FDA.reportPublic FDA data

Claritin

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 01:20:09

Label at a glance#

ProductClaritin
Active ingredientLORATADINE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Dosage and administration

adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

phenylketonurics: contains phenylalanine 1.4 mg per tablet safety sealed: do not use if the individual blister unit imprinted with Children's Claritin® is open or torn store between 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and overchew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of agechew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

  • phenylketonurics: contains phenylalanine 1.4 mg per tablet
  • safety sealed: do not use if the individual blister unit imprinted with Children's Claritin® is open or torn
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate,stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

SPL UNCLASSIFIED SECTION

Dist by: Bayer HealthCare LLC, Whippany, NJ 07981

Product of Ireland

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLARITIN_Children_Grape_Tablet_40ctCLARITIN_Children_Grape_Tablet_40ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
668469Claritin Children's 5 MG 24HR Chewable TabletPSN17
665078loratadine 5 MG 24HR Chewable TabletPSN17
668469loratadine 5 MG Chewable Tablet [Claritin]SBD17
665078loratadine 5 MG Chewable TabletSCD17
668469Claritin 5 MG Chewable TabletSY17

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0104-1Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017
11523-0104-1Claritin1 in 1 CARTONTABLET, CHEWABLE117
11523-0104-2Claritin2 in 1 CARTONTABLET, CHEWABLE217
11523-0104-2Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017
11523-0104-3Claritin3 in 1 CARTONTABLET, CHEWABLE317
11523-0104-3Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017
11523-0104-4Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017
11523-0104-4Claritin4 in 1 CARTONTABLET, CHEWABLE417
11523-0104-5Claritin6 in 1 CARTONTABLET, CHEWABLE617
11523-0104-5Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017
11523-0104-6Claritin8 in 1 CARTONTABLET, CHEWABLE817
11523-0104-6Claritin10 in 1 BLISTER PACKTABLET, CHEWABLE1017

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-010411523-0104-1, 11523-0104-2, 11523-0104-3, 11523-0104-4, 11523-0104-5, 11523-0104-6

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C RED NO. 272LRS185U6KIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
ALUMINUM OXIDELMI26O6933IACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
LORATADINE7AJO3BO7QNACTIB
ASPARTAMEZ0H242BBR1IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210033-001LORATADINELORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1284e616aacf4f…
2026-08-18 06:07:402026-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123f01610625f2…
2019-09-15 20:21 UTC2019-09A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210033-001LORATADINE5MGTABLET, CHEWABLE / ORAL2019-06-12f41ea6bd6efb…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClaritinLORATADINEBayer HealthCare LLC.f3b9c643-a605-7702-e053-2995a90a61302025-12-04WarningsExact identifier
ndc (package): 11523-0104-3
ndc (package): 11523-0104-6
ndc (package): 11523-0104-2
ndc (package): 11523-0104-5
ndc (package): 11523-0104-1
ndc (package): 11523-0104-4
ndc (product): 11523-0104
ndc11 (package): 11523010403
ndc11 (package): 11523010401
ndc11 (package): 11523010404
ndc11 (package): 11523010406
ndc11 (package): 11523010402
ndc11 (package): 11523010405
spl id: 4526d753-7999-0ec3-e063-6294a90a270f
spl set id: f3b9c643-a605-7702-e053-2995a90a6130

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.