Loratadine tablets

Manufacturer: Major Pharmaceuticals
Effective date: 2016-11-03
Label type: HUMAN OTC DRUG LABEL
Version: 19
Source: legacy-cache
Hydrated at: 2026-08-02 01:20:54

Label at a glance#

ProductLoratadine

Active ingredientLORATADINE

Label structure14 sections

Dosage and administration

Adults and children 6 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#

PhoneLabel contact(800) 616-2471

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Loratidine USP 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Use

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 and throat.

Warning

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

OTC - ASK DOCTOR SECTION

liver or kidney disease. You 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 if

OTC - STOP USE SECTION

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

Pregnancy/breast-feeding warning

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 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 at 20º - 25ºC (68º -77ºF); excursions permitted to 15^o- 30^oC (59^o- 86^oF). [ See USP Controlled Room Temperature]

Protect from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch.

Questions?

OTC - QUESTIONS SECTION

Questions or comments? (800) 616-2471

Distributed by:

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive, Livonia, MI 48150 USA

Re-Order No. 301592

PRINCIPAL DISPLAY PANEL LORATADINE TABLETS, USP 10MG

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LORATADINE TABLETS, USP 10MG

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6074-46	EA - Each	0904-6074	5e9647fe-a1cb-4ea0-9f31-8a38bc8e0396	1	2013-02-13
0904-6074-60	EA - Each	0904-6074	350ce3a8-a5c9-4532-baca-588e017ede0b	1	2013-02-13
0904-6074-61	EA - Each	0904-6074	d3d9f1fa-bdaa-4a48-903a-79fcc2ef771d	1	2012-07-24
0904-6074-89	EA - Each	0904-6074	7e5b4c30-eb45-4f8d-8ec7-c918b9f80b0d	1	2013-02-13
51660-526-01	EA - Each	51660-526	23ef566a-7fbc-42f3-aa01-eac9d9a2b120	1	2012-07-24
51660-526-05	EA - Each	51660-526	82cd5b39-27fb-4a5f-8caa-efa85266448a	1	2012-07-24
51660-526-30	EA - Each	51660-526	bd00fc2c-7bf3-47f5-a7cd-7aeaec6fdddb	1	2019-10-07
51660-526-31	EA - Each	51660-526	2d65982b-8238-4b58-a5c6-9732389e4607	1	2012-07-24
51660-526-53	EA - Each	51660-526	16eb7af6-5422-4617-aafa-52f14555717f	1	2018-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	18
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	18
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	18
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	18
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	18

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Loratadine
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0904-6074	0904-6074-61
51660-526

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
LORATADINE	7AJO3BO7QN	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	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 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL	980 mg	Exact identifier — unii+route+dosage form
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loratadine Allergy Relief	LORATADINE	OHM LABORATORIES INC.	c35f2cc1-f76d-4824-b0a5-747bca0c3b85	2023-12-08	Warnings	Exact identifier ndc (product): 51660-526
15a8d9a9-ad90-462b-ad09-0e6336a342d1			dece3618-cc76-4f43-8e0f-25da104fdb54	2016-11-03	Warnings	Exact identifier spl id: 15a8d9a9-ad90-462b-ad09-0e6336a342d1 spl set id: dece3618-cc76-4f43-8e0f-25da104fdb54

Reported adverse events (FAERS/openFDA)#

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