Claritin Chewable

Manufacturer: Bayer HealthCare LLC.
Effective date: 2025-12-05
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:20:21

Label at a glance#

ProductClaritin Chewable Cool Mint Flavor

Active ingredientLORATADINE

Label structure10 sections

Indications and uses

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

Dosage and administration

Directions • chew or crush tablets completely before swallowing adults and children 6 years and over chew 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#

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

Loratadine

OTC - PURPOSE SECTION

Purpose

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

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

Directions

• chew or crush tablets completely before swallowing

adults and children 6 years and over	chew 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

Other information

• phenylketonurics: contains phenylalanine 3 mg per tablet

• safety sealed: do not use if the individual blister unit imprinted with Claritin® is open or torn

• store between 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous citric acid;aspartame;fd&c blue no. 1--aluminum lake;magnesium

stearate;mannitol;menthol;microcrystalline cellulose;silicon dioxide;sodium starch glycolate type a corn;stearic acid

Questions or comments

OTC - QUESTIONS SECTION

Questions or comments?

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

Carton 8 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Cool Mint

10 mg Chewable

Non-Drowsy*

Claritin®

Chewables

loratadine chewable tablets

10 mg/antihistamine

24 Hour Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor

Allergies

Cool Mint

Flavored

*When taken as directed.

See Drug Facts Panel.

8 Chewable Tablets

PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2265267	Claritin 10 MG Chewable Tablet	PSN	5
2265266	loratadine 10 MG Chewable Tablet	PSN	5
2265267	loratadine 10 MG Chewable Tablet [Claritin]	SBD	5
2265266	loratadine 10 MG Chewable Tablet	SCD	5
2265267	Claritin 10 MG Chewable Tablet	SY	5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-4364-1	Claritin ChewableCool Mint Flavor	3 in 1 CARTON	TABLET, CHEWABLE	3	5
11523-4364-1	Claritin ChewableCool Mint Flavor	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	5
11523-4364-2	Claritin ChewableCool Mint Flavor	2 in 1 BLISTER PACK	TABLET, CHEWABLE	2	5
11523-4364-2	Claritin ChewableCool Mint Flavor	1 in 1 CARTON	TABLET, CHEWABLE	1	5
11523-4364-3	Claritin ChewableCool Mint Flavor	4 in 1 BLISTER PACK	TABLET, CHEWABLE	4	5
11523-4364-3	Claritin ChewableCool Mint Flavor	1 in 1 CARTON	TABLET, CHEWABLE	1	5
11523-4364-4	Claritin ChewableCool Mint Flavor	7 in 1 CARTON	TABLET, CHEWABLE	7	5
11523-4364-4	Claritin ChewableCool Mint Flavor	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	5
11523-4364-5	Claritin ChewableCool Mint Flavor	8 in 1 CARTON	TABLET, CHEWABLE	8	5
11523-4364-5	Claritin ChewableCool Mint Flavor	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	5
11523-4364-6	Claritin ChewableCool Mint Flavor	1 in 1 CARTON	TABLET, CHEWABLE	1	5
11523-4364-6	Claritin ChewableCool Mint Flavor	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	5
11523-4364-7	Claritin ChewableCool Mint Flavor	2 in 1 BLISTER PACK	TABLET, CHEWABLE	2	5
11523-4364-7	Claritin ChewableCool Mint Flavor	1 in 1 POUCH	TABLET, CHEWABLE	1	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-4364-1	EA - Each	11523-4364	a888024d-d3f7-43cb-9107-b6e9040b6de0	1	2025-05-14

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Claritin Chewable Cool Mint Flavor
loratadine
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
MAGNESIUM STEARATE
SILICON DIOXIDE
FD&C BLUE NO. 1--ALUMINUM LAKE
MENTHOL
ANHYDROUS CITRIC ACID
ASPARTAME
MANNITOL
MICROCRYSTALLINE CELLULOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-4364	11523-4364-1, 11523-4364-2, 11523-4364-3, 11523-4364-5, 11523-4364-6, 11523-4364-7, 11523-4364-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
STEARIC ACID	4ELV7Z65AP	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
FD&C BLUE NO. 1--ALUMINUM LAKE	J9EQA3S2JM	IACT
MENTHOL	L7T10EIP3A	IACT
LORATADINE	7AJO3BO7QN	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
ASPARTAME	Z0H242BBR1	IACT
MANNITOL	3OWL53L36A	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	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 · 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 Chewable Cool Mint Flavor	LORATADINE	Bayer HealthCare LLC.	98b99bb9-d499-9ab4-e053-2a95a90a6ae6	2025-12-05	Warnings	Exact identifier ndc (package): 11523-4364-4 ndc (package): 11523-4364-7 ndc (package): 11523-4364-3 ndc (package): 11523-4364-1 ndc (package): 11523-4364-2 ndc (package): 11523-4364-6 ndc (package): 11523-4364-5 ndc (product): 11523-4364 ndc11 (package): 11523436406 ndc11 (package): 11523436403 ndc11 (package): 11523436407 ndc11 (package): 11523436404 ndc11 (package): 11523436402 ndc11 (package): 11523436405 ndc11 (package): 11523436401 spl id: 453711b1-0b16-f203-e063-6394a90a34e1 spl set id: 98b99bb9-d499-9ab4-e053-2a95a90a6ae6

Reported adverse events (FAERS/openFDA)#

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