FDA.reportPublic FDA data

Loratidine Orally Disintegrating Tablets, USP

Manufacturer
CVS PHARMACY, INC | Tenshi Kaizen Pvt Ltd
Effective date
2024-01-02
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:06:19

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 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

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 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

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 daily; not more than 1 tablet 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

SPL UNCLASSIFIED SECTION

Manufactured by:

Tenshi Kaizen Private Limited

Bengaluru Rural – 562112, India

Revised: 11/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Indoor & Outdoor Allergies

Children’s

LORATADINE ORALLY

DISINTEGRATING

TABLETS USP, 10 mg

Antihistamine

Allergy Relief

Non-Drowsy*

Original Prescription Strength

24 hour relief of:

Sneezing; Runny nose; Itchy,

watery eyes; Itchy throat or nose

Ages 6 yrs & older

30 ORALLY

DISINTEGRATING

TABLETS
carton imagecarton image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN8
311373loratadine 10 MG Disintegrating Oral TabletSCD8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51316-503-012023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-022023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-032023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-042023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-052023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-062023-02-09C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-012023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-022023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-032023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-042023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-052023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP
51316-503-062023-01-30C16284748780-1f386c64a-288c-0266-e053-dadaa90a7c1aLoratidine Orally Disintegrating Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-503-01LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING108
51316-503-01LORATADINE1 in 1 CARTONTABLET, ORALLY DISINTEGRATING18
51316-503-02LORATADINE20 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING208
51316-503-02LORATADINE2 in 1 CARTONTABLET, ORALLY DISINTEGRATING28
51316-503-03LORATADINE3 in 1 CARTONTABLET, ORALLY DISINTEGRATING38
51316-503-03LORATADINE30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING308
51316-503-04LORATADINE40 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING408
51316-503-04LORATADINE4 in 1 CARTONTABLET, ORALLY DISINTEGRATING48
51316-503-05LORATADINE50 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING508
51316-503-05LORATADINE5 in 1 CARTONTABLET, ORALLY DISINTEGRATING58
51316-503-06LORATADINE6 in 1 CARTONTABLET, ORALLY DISINTEGRATING68
51316-503-06LORATADINE60 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-503LORATADINE TABLET, ORALLY DISINTEGRATING [CVS PHARMACY, INC]8Current NDC, Legacy NDC, 12 package rows20240102_7ed2aec0-4da7-4edc-9998-b96c67c82738.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
51316-50351316-503-02, 51316-503-03, 51316-503-05, 51316-503-06, 51316-503-04, 51316-503-01

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 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
A213294-001LORATADINELORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30

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
2026-09-14 22:38:342026-08A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-3084e616aacf4f…
2026-08-18 06:07:402026-07A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-304b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-308869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213294-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2020-10-30a50c72e98297…

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, INC7ed2aec0-4da7-4edc-9998-b96c67c827382024-01-02WarningsExact identifier
ndc (package): 51316-503-06
ndc (package): 51316-503-05
ndc (package): 51316-503-01
ndc (package): 51316-503-03
ndc (package): 51316-503-02
ndc (package): 51316-503-04
ndc (product): 51316-503
ndc11 (package): 51316050302
ndc11 (package): 51316050303
ndc11 (package): 51316050305
ndc11 (package): 51316050304
ndc11 (package): 51316050306
ndc11 (package): 51316050301
spl id: 0df114fa-ae43-e77d-e063-6294a90a8c36
spl set id: 7ed2aec0-4da7-4edc-9998-b96c67c82738

Reported adverse events (FAERS/openFDA)#

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