loratadine

Manufacturer
Rite Aid Corporation
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:34

Label at a glance#

Productloratadine
Active ingredientLORATADINE
Label structure10 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

• place 1 tablet on tongue; tablet disintegrates, with or without water   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 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 if

OTC - STOP USE SECTION

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • place 1 tablet on tongue; tablet disintegrates, with or without water
  • 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

OTHER SAFETY INFORMATION

  • do not use if printed blister unit is broken or torn
  • store between 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial mint flavor, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FREE FROM | GLUTEN FREE

Compare to the active ingredient of Claritin® RediTabs®

24 HOUR

FOR JUNIORS & UP AGES 6 YEARS & OLDER

ORIGINAL PRESCRIPTION STRENGTH

LORATADINE

ORALLY DISINTEGRATING TABLETS, 10 mg

ANTIHISTAMINE

NON-DROWSY*

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF

Sneezing • Runny nose • Itchy, watery eyes

Itchy throat or nose

ACTUAL SIZE

NO WATER NEEDED

MELTS IN YOUR MOUTH

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

30 TABLETS

loratadine-image
loratadine-image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN3
311373loratadine 10 MG Disintegrating Oral TabletSCD3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0919-0loratadine1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING13
11822-0919-0loratadine30 in 1 CARTONTABLET, ORALLY DISINTEGRATING303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0919LORATADINE TABLET, ORALLY DISINTEGRATING [RITE AID CORPORATION]3Legacy NDC, 2 package rows20231224_004dd408-e3ff-4ba6-b859-beebe364f0e1.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-091911822-0919-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
A076011-001LORATADINELORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29

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 22:38:342026-08A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2984e616aacf4f…
2026-08-18 06:07:402026-07A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-293f01610625f2…
2019-09-15 20:21 UTC2019-09A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29f41ea6bd6efb…

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
2e9d86de-a2ce-46ae-b20b-222fb74e1ff3004dd408-e3ff-4ba6-b859-beebe364f0e12026-09-09WarningsExact identifier
spl set id: 004dd408-e3ff-4ba6-b859-beebe364f0e1

Reported adverse events (FAERS/openFDA)#

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