FDA.reportPublic FDA data

Loratadine Orally Disintegrating Tablets USP

Manufacturer
CVS PHARMACY, INC | Reed-Lane, Inc. | Quality Packaging Specialists International, LLC | Tenshi Kaizen Pvt Ltd
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:49:55

Label at a glance#

ProductLORATADINE
Active ingredientLORATADINE
Label structure11 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 every 12 hours; not more than 2 tablets in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally disintegrating Tablet, USP is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine 5 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

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - WHEN USING SECTION

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant 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

  • place 1 tablet on tongue; tablet disintegrates, with or without water
adults and children 6 years and over1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

  • safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally disintegrating Tablet, USP is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

Questions or comments?

OTC - QUESTIONS SECTION

1-877-244-9825 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day.

SPL UNCLASSIFIED SECTION

Manufactured by:

Tenshi Kaizen Private Limited

Bengaluru Rural – 562112, India

Distributed by:

CVS Pharmacy, Inc.

Revised: 09/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton imagecarton image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
672558loratadine 5 MG Disintegrating Oral TabletPSN6
672558loratadine 5 MG Disintegrating Oral TabletSCD6

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51316-502-012024-12-31C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-022024-12-31C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-032024-12-31C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-042024-12-31C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-052024-12-31C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-062024-12-31C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-012024-07-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-022024-07-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-032024-07-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-042024-07-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-052024-07-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-062024-07-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-012024-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-022024-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-032024-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-042024-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-052024-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-062024-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-012023-02-09C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-022023-02-09C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-032023-02-09C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-042023-02-09C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-052023-02-09C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-062023-02-09C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-012023-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-022023-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-032023-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-042023-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-052023-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP
51316-502-062023-01-30C16284748780-1f386c64a-35d2-0266-e053-dadaa90a7c1aLoratadine Orally Disintegrating Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-502-01LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
51316-502-01LORATADINE1 in 1 CARTONTABLET, ORALLY DISINTEGRATING16
51316-502-02LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
51316-502-02LORATADINE2 in 1 CARTONTABLET, ORALLY DISINTEGRATING26
51316-502-03LORATADINE3 in 1 CARTONTABLET, ORALLY DISINTEGRATING36
51316-502-03LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
51316-502-04LORATADINE4 in 1 CARTONTABLET, ORALLY DISINTEGRATING46
51316-502-04LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
51316-502-05LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
51316-502-05LORATADINE5 in 1 CARTONTABLET, ORALLY DISINTEGRATING56
51316-502-06LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
51316-502-06LORATADINE6 in 1 CARTONTABLET, ORALLY DISINTEGRATING66

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-502LORATADINE TABLET, ORALLY DISINTEGRATING [CVS PHARMACY, INC]6Current NDC, Legacy NDC, 12 package rows20250101_4e74e322-7f6e-467c-96c0-9b531ddb429b.zip

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
51316-50251316-502-01, 51316-502-02, 51316-502-03, 51316-502-04, 51316-502-05, 51316-502-06

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PULLULAN8ZQ0AYU1TTIACT
POLYSORBATE 806OZP39ZG8HIACT
MANNITOL3OWL53L36AIACT
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 44.

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
A212795-001LORATADINELORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18c2088c7a36db…
2026-09-14 22:38:342026-08A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1884e616aacf4f…
2026-08-18 06:07:402026-07A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-184b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212795-001LORATADINE5MGTABLET, ORALLY DISINTEGRATING / ORAL2020-09-18a50c72e98297…

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
LORATADINELORATADINECVS PHARMACY, INC4e74e322-7f6e-467c-96c0-9b531ddb429b2024-12-31WarningsExact identifier
ndc (package): 51316-502-03
ndc (package): 51316-502-01
ndc (package): 51316-502-06
ndc (package): 51316-502-02
ndc (package): 51316-502-05
ndc (package): 51316-502-04
ndc (product): 51316-502
ndc11 (package): 51316050204
ndc11 (package): 51316050203
ndc11 (package): 51316050201
ndc11 (package): 51316050206
ndc11 (package): 51316050205
ndc11 (package): 51316050202
spl id: 28e49606-cbf6-7029-e063-6394a90ae3b7
spl set id: 4e74e322-7f6e-467c-96c0-9b531ddb429b

Reported adverse events (FAERS/openFDA)#

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