FDA.reportPublic FDA data

Alavert

Manufacturer
Foundation Consumer Healthcare
Effective date
2024-06-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:31:50

Label at a glance#

ProductAlavert Allergy
Active ingredientLORATADINE
Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes 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

phenylketonurics: contains phenylalanine 0.56 mg per tablet safety sealed: do not use if the individual blister unit imprinted with Alavert® Citrus Burst is open or torn store at 20-25°C (68-77°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
  • sneezing
  • itchy, watery eyes
  • 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 use more than directed. Taking more than recommended 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

  • phenylketonurics: contains phenylalanine 0.56 mg per tablet
  • safety sealed: do not use if the individual blister unit imprinted with Alavert® Citrus Burst is open or torn
  • store at 20-25°C (68-77°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, aspartame, flavors, mannitol, polysorbate 80, pullulan

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800 ALAVERT (1-800-252-8378) weekdays 9 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

Distributed by: Foundation Consumer Healthcare, LLC
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 60 Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW FORMULA

Compare to the active ingredient in Claritin ® RediTabs ® Original Prescription Strength †

NON-DROWSY*

ALLERGY RELIEF

ALAVERT ®

Loratadine Orally Disintegrating Tablet USP, 10 mg
Antihistamine

Indoor/Outdoor

ALLERGIES

24 Hour Relief of

Sneezing, Runny Nose

Itchy/Watery Eyes

Itchy Throat or Nose

Melts In Your Mouth

CITRUS BURST Flavor

*When taken as directed. See Drug Facts Panel.

VALUE SIZE 60 Orally Disintegrating Tablets

Alavert - 60ctAlavert - 60ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
351855Alavert 10 MG 24HR Disintegrating Oral TabletPSN2
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN2
351855loratadine 10 MG Disintegrating Oral Tablet [Alavert]SBD2
311373loratadine 10 MG Disintegrating Oral TabletSCD2
35185524 HR Alavert 10 MG Disintegrating Oral TabletSY2
351855Alavert 10 MG Disintegrating Oral TabletSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-195-20AlavertAllergy1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING12
69536-195-20AlavertAllergy20 in 1 CARTONTABLET, ORALLY DISINTEGRATING202
69536-195-60AlavertAllergy1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING12
69536-195-60AlavertAllergy60 in 1 CARTONTABLET, ORALLY DISINTEGRATING602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-195ALAVERT ALLERGY (LORATADINE) TABLET, ORALLY DISINTEGRATING [FOUNDATION CONSUMER HEALTHCARE]2Current NDC, 4 package rows20241101_1704474a-9b99-de45-e063-6294a90ac59b.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69536-19569536-195-20, 69536-195-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ASPARTAMEZ0H242BBR1IACT
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
Alavert AllergyLORATADINEFoundation Consumer Healthcare1704474a-9b99-de45-e063-6294a90ac59b2024-06-24WarningsExact identifier
ndc (package): 69536-195-20
ndc (package): 69536-195-60
ndc (product): 69536-195
ndc11 (package): 69536019560
ndc11 (package): 69536019520
spl id: 1ba62e9b-1b1f-016a-e063-6394a90a065e
spl set id: 1704474a-9b99-de45-e063-6294a90ac59b

Reported adverse events (FAERS/openFDA)#

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