Children Claritin

Manufacturer: Bayer HealthCare LLC.
Effective date: 2017-05-16
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 01:16:20

Label at a glance#

ProductChildren Claritin Allergy

Active ingredientLORATADINE

Label structure15 sections

Contacts and useful links#

PhoneLabel contact1-800-252-7484

Websitewww.claritin.com

www.claritin.com

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Use only with enclosed dosing cup

adults and children 6 years and over: 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age: 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) 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

each teaspoonful contains: sodium 6 mg
do not use if tape imprinted with “SEALED FOR YOUR PROTECTION” on top and bottom flaps of carton is not intact.
store between 20° and 25°C (68° and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

edetate disodium, flavor, glycerin, maltitol, monobasic sodium phosphate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments

OTC - QUESTIONS SECTION

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

WARNINGS SECTION

Warnings

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Claritin Oral Solution

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-4360-5	ML - Milliliter	11523-4360	a5947025-273d-428e-9bc1-8472d5c4fae9	1	2019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	1
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	1
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Children Claritin Allergy
loratadine
WATER
SODIUM BENZOATE
GLYCERIN
EDETATE DISODIUM
MALTITOL
SODIUM PHOSPHATE, MONOBASIC
PHOSPHORIC ACID
SORBITOL
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
11523-4360	11523-4360-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
GLYCERIN	PDC6A3C0OX	IACT
LORATADINE	7AJO3BO7QN	ACTIB
EDETATE DISODIUM	7FLD91C86K	IACT
MALTITOL	D65DG142WK	IACT
SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
SORBITOL	506T60A25R	IACT
SUCRALOSE	96K6UQ3ZD4	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 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SOLUTION / ORAL	25 mg/5ml		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SOLUTION / ORAL	25 mg/5ml		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SOLUTION / ORAL		9000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / ORAL		19 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MALTITOL	MALTITOL	D65DG142WK	SOLUTION / ORAL		9000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / ORAL		19 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii+route+dosage form 2 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
N020641-002	CLARITIN	LORATADINE	1MG/ML	SYRUP / ORAL		RLD, RS	2002-11-27
N020641-003	CLARITIN HIVES RELIEF	LORATADINE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL		RLD	2003-11-19

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	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SYRUP / ORAL	RLD	2003-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020641-002	CLARITIN	1MG/ML	SYRUP / ORAL	RLD, RS	2002-11-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020641-003	CLARITIN HIVES RELIEF	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SYRUP / ORAL	RLD	2003-11-19	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Children Claritin Allergy	LORATADINE	Bayer HealthCare LLC.	170061e9-e529-4ff0-e054-00144ff8d46c	2025-05-15	Warnings	Exact identifier ndc (package): 11523-4360-1 ndc (product): 11523-4360 ndc11 (package): 11523436001
4fa3c5fa-d92f-4f52-e054-00144ff88e88			1fdeaf8b-6c6b-7033-e054-00144ff8d46c	2017-05-16	Warnings	Exact identifier spl id: 4fa3c5fa-d92f-4f52-e054-00144ff88e88 spl set id: 1fdeaf8b-6c6b-7033-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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