Loratadine Tablets, 10 mg

Manufacturer: St. Mary's Medical Park Pharmacy
Effective date: 2026-06-29
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: weekly-update
Hydrated at: 2026-07-17 21:42:08

Label at a glance#

ProductLoratadine

Active ingredientLORATADINE

Label structure15 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 consumers with liver or kidney disease ask a doctor

Storage and handling

store between 20º to 25ºC (68º to 77ºF)

Contacts and useful links#

PhoneLabel contact1-877-770-3183

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 10 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

INDICATIONS & USAGE SECTION

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

 runny nose

 sneezing

 itchy, water 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 IF

OTC - ASK DOCTOR SECTION

you have 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 DOCTOR IF

OTC - STOP USE SECTION

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

PREGNANCY/BREASTFEEDING

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 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

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

Blister Foil Units

safety sealed: do not use if the individual blister unit is open or torn

STORAGE

STORAGE AND HANDLING SECTION

store between 20º to 25ºC (68º to 77ºF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

QUESTIONS OR COMMENTS

SPL UNCLASSIFIED SECTION

Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

831-00

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	(01)00370010016234(01)00360760083100(17)000000(30)100(10)???????????????(10)XXXXXXX(8004)0360760.????????		LORATADINE 60760-831-00.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60760-831-00	EA - Each	60760-831	d4308191-62f6-4c77-b041-7039ff471fe2	1	2025-03-04
70010-162-01	EA - Each	70010-162	590b49a0-7416-4a5b-9ef6-cdc10a4b3a3f	1	2021-12-08
70010-162-34	EA - Each	70010-162	9d40ed54-0327-411e-9606-1ffef0f56c90	1	2022-09-12

Products#

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

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

Loratadine
LACTOSE MONOHYDRATE
STARCH, CORN
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60760-831	60760-831-00
70010-162

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
STARCH, CORN	O8232NY3SJ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
LORATADINE	7AJO3BO7QN	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2025-12-08	full-release	2026-06-01 01:20:52

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
A210722-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2019-12-23

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
2026-09-14 22:38:34	2026-08	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210722-001	LORATADINE	10MG	TABLET / ORAL	2019-12-23	`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	St. Mary's Medical Park Pharmacy	2bc586e4-5297-44cf-e063-6294a90a531d	2026-06-29	Warnings	Exact identifier ndc (package): 60760-831-00 ndc (product): 60760-831 ndc11 (package): 60760083100 spl id: 558e2984-e10b-9ce4-e063-6294a90adb9e spl set id: 2bc586e4-5297-44cf-e063-6294a90a531d
Loratadine	LORATADINE	Granules Pharmaceuticals Inc.	d15add22-bc2d-9730-e053-2a95a90acd3f	2025-05-05	Warnings	Exact identifier ndc (product): 70010-162

Reported adverse events (FAERS/openFDA)#

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