Claritin

Manufacturer: Bayer HealthCare LLC.
Effective date: 2025-12-05
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:20:13

Label at a glance#

ProductClaritin

Active ingredientLORATADINE

Label structure14 sections

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Loratadine 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

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

Do Not Use

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

AS a doctor before use if you have

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 and ask a doctor if

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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

phenylketonurics: contains phenylalanine 1.9 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 INGREDIENT SECTION

aspartame, carmine, citric acid, colloidal silicon dioxide, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

OTC - QUESTIONS SECTION

1-800-CLARITIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ages

2 years®

and older

Children's

Claritin®

Chewables

loratadine 5 mg/antihistamine

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel

Non-Drowsy*

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Bubblegum

Flavored

Chewable Tablets

10-count carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
668469	Claritin Children's 5 MG 24HR Chewable Tablet	PSN	8
665078	loratadine 5 MG 24HR Chewable Tablet	PSN	8
668469	loratadine 5 MG Chewable Tablet [Claritin]	SBD	8
665078	loratadine 5 MG Chewable Tablet	SCD	8
668469	Claritin 5 MG Chewable Tablet	SY	8

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0041100811127	GTIN-13: 0041100811127 EAN-13: 0041100811127 GTIN-12: 041100811127 UPC-A: 041100811127 GTIN storage (14 digits): 00041100811127	10 count carton-bubblegum flavored.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-4330-1	Claritin	1 in 1 CARTON	TABLET, CHEWABLE	1	8
11523-4330-1	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	8
11523-4330-3	Claritin	3 in 1 CARTON	TABLET, CHEWABLE	3	8
11523-4330-3	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	8
11523-4330-4	Claritin	4 in 1 CARTON	TABLET, CHEWABLE	4	8
11523-4330-4	Claritin	10 in 1 BLISTER PACK	TABLET, CHEWABLE	10	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-4330-1	EA - Each	11523-4330	93078d7d-91a2-4f15-9d81-ac0927cae624	1	2019-01-24
11523-4330-3	EA - Each	11523-4330	bd6f7514-86e5-4922-bbc2-bc60a35caf2a	1	2022-11-07
11523-4330-4	EA - Each	11523-4330	7d69a0d5-5c6d-4592-8061-99b8d46374f0	1	2022-11-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	1
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	1
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Claritin
loratadine
SILICON DIOXIDE
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
ASPARTAME

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-4330	11523-4330-1, 11523-4330-3, 11523-4330-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STEARIC ACID	4ELV7Z65AP	IACT
LORATADINE	7AJO3BO7QN	ACTIB
ASPARTAME	Z0H242BBR1	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL	254 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL	127 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL	1725 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL	1725 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL	254 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL	1725 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL	3726 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL	180 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE / ORAL	195 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL	3726 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL	180 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL	3726 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL	127 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL	127 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE / ORAL	195 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL	254 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL	180 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL	180 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE / ORAL	3726 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE / ORAL	195 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL	127 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ASPARTAME	ASPARTAME	Z0H242BBR1	TABLET, CHEWABLE / ORAL	195 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL	254 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL	1725 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021891-001	CHILDREN'S CLARITIN	LORATADINE	5MG	TABLET, CHEWABLE / ORAL		RLD	2006-08-23
N021891-002	CLARITIN	LORATADINE	10MG	TABLET, CHEWABLE / ORAL		RLD, RS	2018-11-21

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD	2006-08-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD, RS	2018-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021891-001	CHILDREN'S CLARITIN	5MG	TABLET, CHEWABLE / ORAL	RLD, RS	2006-08-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021891-002	CLARITIN	10MG	TABLET, CHEWABLE / ORAL	RLD	2018-11-21	`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.

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.	20938e05-bc3e-51aa-e054-00144ff88e88	2025-12-05		Exact identifier ndc (package): 11523-4330-1 ndc (package): 11523-4330-4 ndc (package): 11523-4330-3 ndc (product): 11523-4330 ndc11 (package): 11523433004 ndc11 (package): 11523433001 ndc11 (package): 11523433003 spl id: 45370735-3f9c-a7f8-e063-6294a90aa0c6 spl set id: 20938e05-bc3e-51aa-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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