Loratadine Tablets

Manufacturer: Advanced Rx Pharmacy of Tennessee, LLC
Effective date: 2024-12-31
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:50:21

Label at a glance#

ProductLoratadine

Active ingredientLORATADINE

Label structure15 sections

Indications and uses

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

Dosage and administration

adults and children 6 years of age 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

Loratidine is supplied as: Bottles of 30 Tablets NDC: 80425-0352-01 store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)

Contacts and useful links#

PhoneLabel contact1-800-874-7464

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)

Loratadine, 10 mg USP

OTC - PURPOSE SECTION

Purpose

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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

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

Warnings

WARNINGS SECTION

Do not useif you ever have 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 pregnanct 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years of age 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

OTHER SAFETY INFORMATION

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.
Store between 20° - 25°C (68°-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredientscorn starch, lactose monohydrate, magnesium stearate, povidone

OTC - QUESTIONS SECTION

Questions or comments?

Call 1-800-874-7464 Monday to Friday 9 AM to 5 PM EST

How Supplied/ Storage and Handling

HOW SUPPLIED SECTION

Loratidine is supplied as:

Bottles of 30 Tablets NDC: 80425-0352-01

store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311372	loratadine 10 MG 24HR Oral Tablet	PSN	2
311372	loratadine 10 MG Oral Tablet	SCD	2
311372	loratadine 10 MG 24 HR Oral Tablet	SY	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80425-0352-1	Loratadine	30 in 1 BOTTLE	TABLET	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0352	LORATADINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 1 package rows	20250102_01cb43cf-57a9-f189-e063-6294a90afd88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0352-1	EA - Each	80425-0352	f9390c79-9ee4-4e64-97a1-db6be06a7328	1	2023-09-05
16571-822-01	EA - Each	16571-822	3d76a8ea-b185-45c7-a207-052dc7b85a60	1	2022-04-06
16571-822-03	EA - Each	16571-822	d04fcc31-5a7c-4519-ace4-930878ba9dad	1	2022-04-06
16571-822-30	EA - Each	16571-822	05b58fa0-a4a0-45a4-8ebc-e5d6ff043c91	1	2022-04-06

Products#

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

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

Loratadine
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
STARCH, CORN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80425-0352	80425-0352-1
16571-822

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	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 44.

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
A214684-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2021-01-07

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214684-001	LORATADINE	10MG	TABLET / ORAL	2021-01-07	`a50c72e98297…`

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	LORATADINE	Advanced Rx Pharmacy of Tennessee, LLC	01cb43cf-57a9-f189-e063-6294a90afd88	2024-12-31	Warnings	Exact identifier ndc (package): 80425-0352-1 ndc (product): 80425-0352 ndc11 (package): 80425035201 spl id: 2a9c2eb6-a6de-f647-e063-6294a90a93fe spl set id: 01cb43cf-57a9-f189-e063-6294a90afd88
Loratadine	LORATADINE	Rising Pharmaceuticals, Inc	d28128a3-af54-440e-9bd4-0fccf393d18a	2022-03-10	Warnings	Exact identifier ndc (product): 16571-822

Reported adverse events (FAERS/openFDA)#

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