FDA.reportPublic FDA data

Loratadine

Manufacturer
Contract Pharmacy Services-PA | Coupler Enterprises
Effective date
2017-09-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:32

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

Loratadine 10 mg LabelLoratadine 10 mg Label

NDC 67046-453-30 Non-Drowsy*

Loratadine

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

30 Tablets

SANDOZ

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose

* When taken as directed.

See Drug Facts Panel.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN1
311372loratadine 10 MG Oral TabletSCD1
311372loratadine 10 MG 24 HR Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-453-072022-01-28C16284748780-1d6a99b39-e9ce-a426-e053-dadaa90af4c2Drug Facts 453
67046-453-142022-01-28C16284748780-1d6a99b39-e9ce-a426-e053-dadaa90af4c2Drug Facts 453
67046-453-152022-01-28C16284748780-1d6a99b39-e9ce-a426-e053-dadaa90af4c2Drug Facts 453
67046-453-212022-01-28C16284748780-1d6a99b39-e9ce-a426-e053-dadaa90af4c2Drug Facts 453
67046-453-282022-01-28C16284748780-1d6a99b39-e9ce-a426-e053-dadaa90af4c2Drug Facts 453
67046-453-302022-01-28C16284748780-1d6a99b39-e9ce-a426-e053-dadaa90af4c2Drug Facts 453
67046-453-602022-01-28C16284748780-1d6a99b39-e9ce-a426-e053-dadaa90af4c2Drug Facts 453

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-453-07Loratadine7 in 1 BLISTER PACKTABLET71
67046-453-14Loratadine14 in 1 BLISTER PACKTABLET141
67046-453-15Loratadine15 in 1 BLISTER PACKTABLET151
67046-453-21Loratadine21 in 1 BLISTER PACKTABLET211
67046-453-28Loratadine28 in 1 BLISTER PACKTABLET281
67046-453-30Loratadine30 in 1 BLISTER PACKTABLET301
67046-453-60Loratadine60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-453LORATADINE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 7 package rows20170920_59905847-f1a5-0dee-e053-2a91aa0aafed.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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
67046-45367046-453-07, 67046-453-14, 67046-453-15, 67046-453-21, 67046-453-28, 67046-453-30, 67046-453-60
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 · Source PDF

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
59905847-f1a6-0dee-e053-2a91aa0aafed59905847-f1a5-0dee-e053-2a91aa0aafed2017-09-19WarningsExact identifier
spl id: 59905847-f1a6-0dee-e053-2a91aa0aafed
spl set id: 59905847-f1a5-0dee-e053-2a91aa0aafed

Reported adverse events (FAERS/openFDA)#

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