FDA.reportPublic FDA data

Loratadine Orally Disintegrating Tablets USP 10 mg

Manufacturer
Wal-Mart Stores, Inc. | Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2022-11-04
Label type
Human OTC Drug Label
Version
4
Source
full-release
Hydrated at
2026-05-31 23:51:26

Label at a glance#

ProductLoratadine ODT
Active ingredientLORATADINE
Label structure14 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 2.25 mg per tablet do not use if the individual blister unit is open or torn store at 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister Complies with USP test 2 for Disintegration

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine USP 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

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 (1-800-222-1222) 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 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

STORAGE AND HANDLING SECTION

  • Phenylketonurics: Contains phenylalanine 2.25 mg per tablet
  • do not use if the individual blister unit is open or torn
  • store at 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister
  • Complies with USP test 2 for Disintegration

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, crospovidone, mannitol, microcrystalline cellulose,  peppermint, pregelatinized starch (maize), sodium stearyl fumarate

Questions or comments?

OTC - QUESTIONS SECTION

DISTRIBUTED BY: Walmart Inc,.
Bentonville, AR 72716
This Product is not manufactured or distributed
by Bayer HealthCare LLC, distributor of claritin®RediTabs®

Manufactured for :
AUROHEALTH LLC
2572 Brunswick Pikg
Lawrenceville, NJ 08684

Manufactured by :
Aurobindo Pharma Limited
Unit- VII (SEZ)
Mahabubnagar (Dt) -509302
India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-806-09

equateTM

 

Compared to
the active        

Ingredient

In Claritin®

RediTabs®**

 

Non-Drowsy*

Loratadine Orally Disintegrating                      Dissolves

Tablets USP 10 mg                                          in Your Mouth
Antihistamine

Indoor & Outdoor Allergy Relief

24 Hour Relief Of:

  • Sneezing
  • Runny nose                                              24
  • Itchy, watery eyes                                 HOUR
  • Itchy throat or nose

Original  Prescription Strength                                                 

                                                                                             30    
*When taken as directed. See Drug Facts Panel.     TABLETS   (3 x 10) Orally Disintegrating Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating TabletsPACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN4
311373loratadine 10 MG Disintegrating Oral TabletSCD4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-806-09Loratadine ODT3 in 1 CARTONTABLET, ORALLY DISINTEGRATING34
49035-806-09Loratadine ODT10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-806LORATADINE ODT (LORATADINE) TABLET, ORALLY DISINTEGRATING [WAL-MART STORES, INC.]4Current NDC, Legacy NDC, 2 package rows20221108_f399f7ab-ab51-46ff-bce9-3014eb021930.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-806-03EA - Each49035-80629bc985c-e772-4aca-aede-61203edfa06512025-07-08
49035-806-09EA - Each49035-80682f9ee1c-b48a-40da-9eb3-a718601822af12023-06-06

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-80649035-806-09

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LORATADINE7AJO3BO7QNACTIB
ASPARTAMEZ0H242BBR1IACT
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
MANNITOL3OWL53L36AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PEPPERMINTV95R5KMY2BIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT

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
A208477-001LORATADINELORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11c2088c7a36db…
2026-09-14 22:38:342026-08A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1184e616aacf4f…
2026-08-18 06:07:402026-07A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-113f01610625f2…
2019-09-15 20:21 UTC2019-09A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208477-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2018-04-113a93d1ddd44b…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine ODTLORATADINEWal-Mart Stores, Inc.7679ee14-08aa-459c-9107-1a71443799622025-01-23WarningsExact identifier
ndc (product): 49035-806
Loratadine ODTLORATADINEWal-Mart Stores, Inc.f399f7ab-ab51-46ff-bce9-3014eb0219302022-11-04WarningsExact identifier
ndc (package): 49035-806-09
ndc (product): 49035-806
ndc11 (package): 49035080609
spl id: f4838dba-ad33-4f62-8544-6776be255229
spl set id: f399f7ab-ab51-46ff-bce9-3014eb021930

Reported adverse events (FAERS/openFDA)#

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