FDA.reportPublic FDA data

Loratadine

Manufacturer
St. Mary’s Medical Park Pharmacy
Effective date
2018-11-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:47:05

Label at a glance#

ProductLoratadine
Active ingredientLORATADINE
Label structure9 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

Label contents#

Full prescribing information#

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

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 you have

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.

If pregnant or breast-feeding,

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

  • Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
  • Safety sealed: do not use if open or torn (for blister package only).

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-525-8747

SPL UNCLASSIFIED SECTION

10-2015M

Sandoz Inc.

Princeton, NJ 08540

10 mg Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

loralora

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-650-30EA - Each60760-65037e4cd0c-f2cb-4d31-bb37-99df404ae68612018-01-12
0781-5077-01EA - Each0781-5077ee2bd65b-3fef-4be8-badd-bf30aea9e7c912012-07-24
0781-5077-64EA - Each0781-5077d1533bfe-0d09-41a8-b3de-70ebebf3c12b12012-07-24
0781-5077-76EA - Each0781-50777f0bca63-8292-4908-b293-10884106fc8812013-02-11

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60760-65060760-650-30
0781-5077

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
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
LORATADINE7AJO3BO7QNACTIB

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075209-001LORATADINELORATADINE10MGTABLET / ORAL2003-01-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075209-001LORATADINE10MGTABLET / ORAL2003-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075209-001LORATADINE10MGTABLET / ORAL2003-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075209-001LORATADINE10MGTABLET / ORAL2003-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075209-001LORATADINE10MGTABLET / ORAL2003-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075209-001LORATADINE10MGTABLET / ORAL2003-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075209-001LORATADINE10MGTABLET / ORAL2003-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075209-001LORATADINE10MGTABLET / ORAL2003-01-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-213f01610625f2…
2019-09-15 20:21 UTC2019-09A075209-001LORATADINE10MGTABLET / ORAL2003-01-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075209-001LORATADINE10MGTABLET / ORAL2003-01-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075209-001LORATADINE10MGTABLET / ORAL2003-01-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075209-001LORATADINE10MGTABLET / ORAL2003-01-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075209-001LORATADINE10MGTABLET / ORAL2003-01-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075209-001LORATADINE10MGTABLET / ORAL2003-01-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A075209-001LORATADINE10MGTABLET / ORAL2003-01-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A075209-001LORATADINE10MGTABLET / ORAL2003-01-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075209-001LORATADINE10MGTABLET / ORAL2003-01-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075209-001LORATADINE10MGTABLET / ORAL2003-01-21f41ea6bd6efb…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d27d9826-9361-43a7-e053-2a95a90aa59560cc56d0-ee4d-e1dd-e053-2991aa0a104a2021-12-06WarningsExact identifier
spl set id: 60cc56d0-ee4d-e1dd-e053-2991aa0a104a

Reported adverse events (FAERS/openFDA)#

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