Allergy

Manufacturer: Selder, S.A. de C.V.
Effective date: 2016-12-22
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:18:01

Label at a glance#

ProductAllergy

Active ingredientLORATADINE

Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ sneezing ■ runny nose ■ itchy, watery eyes ■ itching of the nose or throat.

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 Consumers with liver or kidney disease: ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-952-0050

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■ sneezing

■ runny nose

■ itchy, watery eyes

■ itching of the nose or throat.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use

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

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor

OTC - STOP USE SECTION

if an allergic reaction to this product occurs. Seek medical help right away.

Pregnancy/Breastfeeding

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 accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION 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

Consumers with liver or kidney disease: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

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

■ protect from excessive moisture

■ do not use if blister packaging is torn or open

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-952-0050 Monday through Friday 9 AM - 5 PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XL-3 Allergy Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311372	loratadine 10 MG 24HR Oral Tablet	PSN	4
311372	loratadine 10 MG Oral Tablet	SCD	4
311372	loratadine 10 MG 24 HR Oral Tablet	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63654-309-10	2020-06-16	C162847	48780-1	9d75b9d0-43de-f424-e053-dadaa90a57ce	309 - XL-3 Allergy
63654-309-10	2020-01-31	C162847	48780-1	9d75b9d0-43de-f424-e053-dadaa90a57ce	309 - XL-3 Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63654-309-10	Allergy	1 in 1 CARTON	TABLET	1		4
63654-309-10	Allergy	10 in 1 BLISTER PACK	TABLET	10		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63654-309	ALLERGY (LORATADINE) TABLET [SELDER, S.A. DE C.V.]	4	Current NDC, Legacy NDC, 2 package rows	20200617_afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Allergy
Loratadine
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63654-309	63654-309-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LORATADINE	7AJO3BO7QN	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076471-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2006-02-14

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076471-001	LORATADINE	10MG	TABLET / ORAL	2006-02-14	`f41ea6bd6efb…`

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
Allergy	LORATADINE	Selder, S.A. de C.V.	afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251	2016-12-22	Warnings	Exact identifier ndc (package): 63654-309-10 ndc (product): 63654-309 ndc11 (package): 63654030910 spl id: 39201d37-e750-420b-8035-feb97bc77c21 spl set id: afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251

Reported adverse events (FAERS/openFDA)#

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