Claritin

Manufacturer: R J General Corporation
Effective date: 2025-11-17
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:16:30

Label at a glance#

ProductClaritin

Active ingredientLORATADINE

Label structure8 sections

Dosage and administration

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 consumer 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#

CLARITIN ®

OTC - ACTIVE INGREDIENT SECTION

*Active ingredients (in each tablet)*	*Purpose*
Loratadine 10 mg	Antihistamine

USE

SPL UNCLASSIFIED 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

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 liver or kidney disease. your doctor should determine if you need a different dose.

When using this productdon not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask doctor ifan allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,ask health professional before use.

Keep out of reach of children.in case of overdose, get medical help or contact a Poison Control Center right away.

Directions

SPL UNCLASSIFIED SECTION


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
consumer with liver or kidney disease	ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Safety sealed: do not use if the individual blister unit imprinted with Claritin ^®is open or torn
Store between 20 ^o to 25 ^{o C}(68 ^oto 77 ^oF)
Protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Corn starch, lactose monohydrate, magnesium stearate

Questions and Comments?

SPL UNCLASSIFIED SECTION

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

Dist. by: Bayer HealthCare LLC

Whippany, NJ 07981

Product of India

Do not use if pouch is torn or broken.

Repackaged and distributed by:

RJ General

2024 Northwest Drive

Cincinnati OH 45231

PRINCIPAL DISPLAY PANEL - 25 Tablet Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non-Drowsy*

Claritin ^®

loratadine tablets 10 mg/ antihistamine

Indoor & Outdoor Allergies

Relief of:

runny nose
itchy, watery eyes
sneezing
itching of the throat or nose

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
206805	Claritin 24HR Allergy 10 MG Oral Tablet	PSN	4
311372	loratadine 10 MG 24HR Oral Tablet	PSN	4
206805	loratadine 10 MG Oral Tablet [Claritin]	SBD	4
311372	loratadine 10 MG Oral Tablet	SCD	4
206805	Claritin 10 MG 24 HR Oral Tablet	SY	4
206805	Claritin 10 MG Oral Tablet	SY	4
311372	loratadine 10 MG 24 HR Oral Tablet	SY	4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70264-030-01	Claritin	1 in 1 POUCH	TABLET	1		4
70264-030-01	Claritin	25 in 1 CARTON	TABLET	25		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-6655-1	EA - Each	11523-6655	dde71ab6-6809-4ac7-a7d9-9d9c742a2b8f	1	2024-04-05
11523-6655-2	EA - Each	11523-6655	5605a8ba-b61d-432a-ad81-9fb5116f9d46	1	2015-03-03
11523-6655-6	EA - Each	11523-6655	91e9062d-e1f2-4e78-9761-7f65d491a10a	1	2015-10-02
11523-6655-8	EA - Each	11523-6655	ea2498f1-91fa-4f87-ab4c-62a689bc2308	1	2017-06-15

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

Claritin
Loratadine
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70264-030	70264-030-01
11523-6655

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STARCH, CORN	O8232NY3SJ	IACT
LORATADINE	7AJO3BO7QN	ACTIB

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
N019658-002	CLARITIN	LORATADINE	10MG	TABLET / ORAL		RLD, RS	2002-11-27
N019658-003	CLARITIN HIVES RELIEF	LORATADINE	10MG	TABLET / ORAL		RLD, RS	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	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	2003-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019658-002	CLARITIN	10MG	TABLET / ORAL	RLD, RS	2002-11-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019658-003	CLARITIN HIVES RELIEF	10MG	TABLET / ORAL	RLD, RS	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
Claritin	LORATADINE	Bayer HealthCare LLC	ac32d6f9-f553-4d5c-ad36-575af5ea56de	2025-12-04	Warnings	Exact identifier ndc (product): 11523-6655
Claritin	LORATADINE	R J General Corporation	a34e8cb7-4fdf-45be-b288-45d93eef6220	2025-11-17	Warnings	Exact identifier ndc (package): 70264-030-01 ndc (product): 70264-030 ndc11 (package): 70264003001 spl id: 43c8f3f3-5cc5-a286-e063-6294a90a6192 spl set id: a34e8cb7-4fdf-45be-b288-45d93eef6220

Reported adverse events (FAERS/openFDA)#

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