FDA.reportPublic FDA data

Claritin

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

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

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Loratadine, 10 mg USP

OTC - PURPOSE SECTION

Purpose

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.

Ask a doctor

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.

When using this product

OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

OTHER SAFETY INFORMATION

■ store at 20º -25º C (68º -77º F) (see USP Controlled Room Temperature)

INACTIVE INGREDIENT SECTION

Inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

OTC - QUESTIONS SECTION

Questions or comments?

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

Carton label 10 count tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

Non-Drowsy*

Claritin®

loratadine tablets 10 mg/antihistamine

Indoor & Outdoor

Allergies

24

Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

*When taken as directed.

See Drug Facts Panel

Carton label 10 countCarton label 10 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
206805Claritin 24HR Allergy 10 MG Oral TabletPSN12
311372loratadine 10 MG 24HR Oral TabletPSN12
206805loratadine 10 MG Oral Tablet [Claritin]SBD12
311372loratadine 10 MG Oral TabletSCD12
206805Claritin 10 MG 24 HR Oral TabletSY12
206805Claritin 10 MG Oral TabletSY12
311372loratadine 10 MG 24 HR Oral TabletSY12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0007-1Claritin1 in 1 CARTONTABLET112
11523-0007-1Claritin10 in 1 BLISTER PACKTABLET1012
11523-0007-2Claritin10 in 1 BLISTER PACKTABLET1012
11523-0007-2Claritin2 in 1 CARTONTABLET212
11523-0007-3Claritin30 in 1 BOTTLETABLET3012
11523-0007-4Claritin40 in 1 BOTTLETABLET4012
11523-0007-5Claritin45 in 1 BOTTLETABLET4512
11523-0007-6Claritin70 in 1 BOTTLETABLET7012
11523-0007-7Claritin85 in 1 BOTTLETABLET8512
11523-0007-8Claritin115 in 1 BOTTLETABLET11512
11523-0007-8Claritin2 in 1 CARTONTABLET212
11523-0007-9Claritin60 in 1 BOTTLETABLET6012

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-000711523-0007-1, 11523-0007-2, 11523-0007-3, 11523-0007-7, 11523-0007-4, 11523-0007-5, 11523-0007-8, 11523-0007-9, 11523-0007-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
LORATADINE7AJO3BO7QNACTIB
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT

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
A075209-001LORATADINELORATADINE10MGTABLET / ORAL2003-01-21

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 22:38:342026-08A075209-001LORATADINE10MGTABLET / ORAL2003-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075209-001LORATADINE10MGTABLET / ORAL2003-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075209-001LORATADINE10MGTABLET / ORAL2003-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075209-001LORATADINE10MGTABLET / ORAL2003-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075209-001LORATADINE10MGTABLET / ORAL2003-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075209-001LORATADINE10MGTABLET / ORAL2003-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075209-001LORATADINE10MGTABLET / ORAL2003-01-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-213f01610625f2…
2019-09-15 20:21 UTC2019-09A075209-001LORATADINE10MGTABLET / ORAL2003-01-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A075209-001LORATADINE10MGTABLET / ORAL2003-01-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-21f41ea6bd6efb…

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.acf2d393-53d7-062f-e053-2995a90a0d602025-12-04WarningsExact identifier
ndc (package): 11523-0007-8
ndc (package): 11523-0007-3
ndc (package): 11523-0007-5
ndc (package): 11523-0007-2
ndc (package): 11523-0007-9
ndc (package): 11523-0007-6
ndc (package): 11523-0007-1
ndc (package): 11523-0007-4
ndc (package): 11523-0007-7
ndc (product): 11523-0007
ndc11 (package): 11523000702
ndc11 (package): 11523000708
ndc11 (package): 11523000701
ndc11 (package): 11523000705
ndc11 (package): 11523000706
ndc11 (package): 11523000707
ndc11 (package): 11523000703
ndc11 (package): 11523000709
ndc11 (package): 11523000704
spl id: 4526b265-4250-3e71-e063-6294a90a21a8
spl set id: acf2d393-53d7-062f-e053-2995a90a0d60

Reported adverse events (FAERS/openFDA)#

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