Loratadine Allergy Relief

Manufacturer: Marlex Pharmaceuticals, Inc.
Effective date: 2025-11-18
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:16:53

Label at a glance#

ProductLoratadine Allergy Relief

Active ingredientLORATADINE

Label structure10 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

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

Storage and handling

store between 20° to 25° C (68° to 77° F) protect from excessive moisture TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine, USP 10 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 useif 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 haveliver or kidney disease. Your doctor should determine if you need a different dose.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifan 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 (1-800-222-1222).

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

STORAGE AND HANDLING SECTION

store between 20° to 25° C (68° to 77° F)
protect from excessive moisture
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

SPL UNCLASSIFIED SECTION

Manufactured for/ Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 10/22 SP

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loratadine 10mg Tablets

NDC 10135-0763-30

30 Tablets

label1

Loratadine 10mg Tablets

NDC 10135-0763-90

90 Tablets

763-90

Loratadine 10mg Tablets

NDC 10135-0763-03

300 Tablets

label3

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10135-763-03	Loratadine Allergy Relief	300 in 1 BOTTLE	TABLET	300	4
10135-763-30	Loratadine Allergy Relief	30 in 1 BOTTLE	TABLET	30	4
10135-763-90	Loratadine Allergy Relief	90 in 1 BOTTLE	TABLET	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-763-03	EA - Each	10135-763	76665c6a-5ac2-40b1-80ff-22c45b0cde22	1	2022-11-07
10135-763-30	EA - Each	10135-763	2dfb202a-eb54-432c-9f08-82a4f9b760c9	1	2022-11-07
10135-763-90	EA - Each	10135-763	3dd4b12f-6fb4-452c-b70e-cd3ba9f834b5	1	2022-11-07

Products#

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

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

Loratadine Allergy Relief
Loratadine
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10135-763	10135-763-30, 10135-763-90, 10135-763-03

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
LORATADINE	7AJO3BO7QN	ACTIB
STARCH, CORN	O8232NY3SJ	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
A076134-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2003-08-18

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	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076134-001	LORATADINE	10MG	TABLET / ORAL	2003-08-18	`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
Loratadine Allergy Relief	LORATADINE	Marlex Pharmaceuticals, Inc.	ec08a6ee-3d71-0fa9-e053-2995a90a9cb1	2025-11-18	Warnings	Exact identifier ndc (package): 10135-763-30 ndc (package): 10135-763-03 ndc (package): 10135-763-90 ndc (product): 10135-763 ndc11 (package): 10135076330 ndc11 (package): 10135076390 ndc11 (package): 10135076303 spl id: 43e1e645-7da5-86de-e063-6394a90a7f3a spl set id: ec08a6ee-3d71-0fa9-e053-2995a90a9cb1

Reported adverse events (FAERS/openFDA)#

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