Claritin

Manufacturer: Bayer HealthCare LLC.
Effective date: 2025-12-04
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 01:20:07

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-252-7484

Websitewww.claritin.com

www.claritin.com

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 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

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

Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

*When taken as directed.

See Drug Facts Panel

Carton label 10 count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
206805	Claritin 24HR Allergy 10 MG Oral Tablet	PSN	10
311372	loratadine 10 MG 24HR Oral Tablet	PSN	10
206805	loratadine 10 MG Oral Tablet [Claritin]	SBD	10
311372	loratadine 10 MG Oral Tablet	SCD	10
206805	Claritin 10 MG 24 HR Oral Tablet	SY	10
206805	Claritin 10 MG Oral Tablet	SY	10
311372	loratadine 10 MG 24 HR Oral Tablet	SY	10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-0800-1	Claritin	5 in 1 BLISTER PACK	TABLET	5	10
11523-0800-1	Claritin	1 in 1 CARTON	TABLET	1	10
11523-0800-2	Claritin	100 in 1 BOTTLE	TABLET	100	10

Products#

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

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

Claritin
loratadine
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-0800	11523-0800-1, 11523-0800-2

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
Name	UNII	Kind
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
LORATADINE	7AJO3BO7QN	ACTIB
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075209-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2003-01-21

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075209-001	LORATADINE	10MG	TABLET / ORAL	2003-01-21	`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.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Claritin	LORATADINE	Bayer HealthCare LLC.	dc65f7ec-bb83-7b29-e053-2995a90a99de	2025-12-04	Warnings	Exact identifier ndc (package): 11523-0800-1 ndc (package): 11523-0800-2 ndc (product): 11523-0800 ndc11 (package): 11523080002 ndc11 (package): 11523080001 spl id: 4526e2eb-ee8d-3ac4-e063-6394a90a133f spl set id: dc65f7ec-bb83-7b29-e053-2995a90a99de

Reported adverse events (FAERS/openFDA)#

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