FDA.reportPublic FDA data

Allervarx Loratadine Orally Disintegrating Tablets USP, 5 mg

Manufacturer
Innovus Pharmaceuticals, Inc. | Tenshi Kaizen Pvt Ltd
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:49:21

Label at a glance#

ProductAllervarx
Active ingredientLORATADINE
Label structure14 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 

Label contents#

Full prescribing information#

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 ageask a doctor
 consumers with liver or kidney diseaseask a doctor 

Other Information 

OTHER SAFETY INFORMATION

  • 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

1-888-278-1784 - 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTONCARTON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
672558loratadine 5 MG Disintegrating Oral TabletPSN3
672558loratadine 5 MG Disintegrating Oral TabletSCD3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57483-955-05Allervarx3 in 1 CARTONTABLET, ORALLY DISINTEGRATING33
57483-955-05Allervarx10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-955ALLERVARX (LORATADINE) TABLET, ORALLY DISINTEGRATING [INNOVUS PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20241228_ec4d1e77-6995-4228-8e63-a9ab6232dace.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57483-95557483-955-05

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
LORATADINE7AJO3BO7QNACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PULLULAN8ZQ0AYU1TTIACT
POLYSORBATE 806OZP39ZG8HIACT
MANNITOL3OWL53L36AIACT

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
AllervarxLORATADINEInnovus Pharmaceuticals, Inc.ec4d1e77-6995-4228-8e63-a9ab6232dace2024-12-27WarningsExact identifier
ndc (package): 57483-955-05
ndc (product): 57483-955
ndc11 (package): 57483095505
spl id: a0d195de-77a2-4627-bcaf-6fa13549882c
spl set id: ec4d1e77-6995-4228-8e63-a9ab6232dace

Reported adverse events (FAERS/openFDA)#

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