Claritin Chewable Grape and Bubblegum

Manufacturer: Bayer HealthCare LLC.
Effective date: 2025-12-04
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:19:35

Label at a glance#

ProductClaritin Chewable Grape and Bubblegum

Active ingredientLORATADINE

Label structure9 sections

Indications and 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

chew or crush tablets completely before swallowing. adults and children 6 years and over chew 2 tablets daily; not more than 2 chewable tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable 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: grape flavor contains phenylalanine 1.4 mg per chewable tablet bubblegum flavor contains phenylalanine 1.9 mg per chewable 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)

Contacts and useful links#

PhoneLabel contact1-800-252-7484

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 ●itchy, watery eyes ●sneezing ●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

chew or crush tablets completely before swallowing.

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

Other Information

STORAGE AND HANDLING SECTION

phenylketonurics:

grape flavor contains phenylalanine 1.4 mg per chewable tablet
bubblegum flavor contains phenylalanine 1.9 mg per chewable 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

Grape chewable tablets

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic aicd

Bubblegum chewable tablets

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-CLARITIN (1-800-252-7484)

PRINCIPAL DISPLAY PANEL - 40 Chewable Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VARIETY PACK

ages
2 +

years

Non-Drowsy*

Children's
Claritin ®

Chewables

loratadine chewable tablets

5 mg/antihistamine

24 Hour

Non-Drowsy* Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor Allergies

20 Grape Flavored

20 Bubblegum Flavored

*When taken as directed. See Drug Facts Panel.

40 CHEWABLE TABLETS

Childrens Chewables 5mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
668469	Claritin Children's 5 MG 24HR Chewable Tablet	PSN	2
665078	loratadine 5 MG 24HR Chewable Tablet	PSN	2
668469	loratadine 5 MG Chewable Tablet [Claritin]	SBD	2
665078	loratadine 5 MG Chewable Tablet	SCD	2
668469	Claritin 5 MG Chewable Tablet	SY	2

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0000000000000	GTIN-13: 0000000000000 EAN-13: 0000000000000 GTIN-12: 000000000000 UPC-A: 000000000000 GTIN storage (14 digits): 00000000000000	Childrens Chewables 5mg Grape Bubblegum 40ct.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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	Strength	SPL version
11523-0123-1	Claritin Chewable Grape and Bubblegum	1 in 1 CARTON	KIT	1		2

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

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Claritin Chewable Grape and Bubblegum
Loratadine
Claritin
ASPARTAME
SILICON DIOXIDE
MAGNESIUM STEARATE
STEARIC ACID
ANHYDROUS CITRIC ACID
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C RED NO. 27
FD&C BLUE NO. 2
MANNITOL
CELLULOSE, MICROCRYSTALLINE
CARMINIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-0123	11523-0123-1
11523-4331
11523-4330

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASPARTAME	Z0H242BBR1	IACT
LORATADINE	7AJO3BO7QN	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STEARIC ACID	4ELV7Z65AP	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
D&C RED NO. 27	2LRS185U6K	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
MANNITOL	3OWL53L36A	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
ASPARTAME	Z0H242BBR1	IACT
LORATADINE	7AJO3BO7QN	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
CARMINIC ACID	CID8Z8N95N	IACT
MANNITOL	3OWL53L36A	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
STEARIC ACID	4ELV7Z65AP	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Claritin	LORATADINE	Bayer HealthCare LLC.	37732ca2-b454-4215-91a2-c62e0f7a56af	2025-12-05	Warnings	Exact identifier ndc (product): 11523-4331
Claritin	LORATADINE	Bayer HealthCare LLC.	20938e05-bc3e-51aa-e054-00144ff88e88	2025-12-05		Exact identifier ndc (product): 11523-4330
Claritin Chewable Grape and Bubblegum	LORATADINE	Bayer HealthCare LLC.	0371368b-dca6-af2f-e063-6394a90a0ac0	2025-12-04	Warnings	Exact identifier ndc (package): 11523-0123-1 ndc (product): 11523-0123 ndc11 (package): 11523012301 spl id: 4526df19-7a6e-0f19-e063-6394a90a3954 spl set id: 0371368b-dca6-af2f-e063-6394a90a0ac0

Reported adverse events (FAERS/openFDA)#

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