FDA.reportPublic FDA data

Loratadine Tablets USP 10 mg

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2022-11-03
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-05-31 23:51:20

Label at a glance#

ProductLoratadine
Active ingredientLORATADINE
Label structure15 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

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

Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken store at 20° to 25°C (68° to 77°F) protect from excessive moisture

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                                                                    
  • itchy, watery eyes
  • sneezing 
  • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

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

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


  • Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?

OTC - QUESTIONS SECTION


call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
 Made in India
Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-831-17
PH primary Health
Non-Drowsy*
Allergy Relief
Loratadine Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

24 Hour

 *When taken
as directed
See Drug
Facts Panel.             45 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-831-17
PH primary Health
Non-Drowsy*
Allergy Relief
Loratadine Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

24 Hour

 *When taken
as directed
See Drug
Facts Panel.             45 Tablets
fig2fig2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN3
311372loratadine 10 MG Oral TabletSCD3
311372loratadine 10 MG 24 HR Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-831-17Loratadine1 in 1 CARTONTABLET13
58602-831-17Loratadine45 in 1 BOTTLETABLET453
58602-831-19Loratadine1 in 1 CARTONTABLET13
58602-831-19Loratadine90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-831LORATADINE TABLET [AUROHEALTH LLC]3Current NDC, Legacy NDC, 4 package rows20221104_839e2e03-9ebb-4a44-b753-fb174bd36115.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
58602-83158602-831-17, 58602-831-19

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
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

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
A208314-001LORATADINELORATADINE10MGTABLET / ORAL2018-04-16

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208314-001LORATADINE10MGTABLET / ORAL2018-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208314-001LORATADINE10MGTABLET / ORAL2018-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A208314-001LORATADINE10MGTABLET / ORAL2018-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208314-001LORATADINE10MGTABLET / ORAL2018-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208314-001LORATADINE10MGTABLET / ORAL2018-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208314-001LORATADINE10MGTABLET / ORAL2018-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208314-001LORATADINE10MGTABLET / ORAL2018-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208314-001LORATADINE10MGTABLET / ORAL2018-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A208314-001LORATADINE10MGTABLET / ORAL2018-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A208314-001LORATADINE10MGTABLET / ORAL2018-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208314-001LORATADINE10MGTABLET / ORAL2018-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208314-001LORATADINE10MGTABLET / ORAL2018-04-16f41ea6bd6efb…

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
LoratadineLORATADINEAurohealth LLC839e2e03-9ebb-4a44-b753-fb174bd361152022-11-03WarningsExact identifier
ndc (package): 58602-831-17
ndc (package): 58602-831-19
ndc (product): 58602-831
ndc11 (package): 58602083117
ndc11 (package): 58602083119
spl id: de409efa-eff4-47fb-a6c6-a22be0587553
spl set id: 839e2e03-9ebb-4a44-b753-fb174bd36115

Reported adverse events (FAERS/openFDA)#

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