Guardian Loratadine Tablets

Manufacturer
Guardian Drug Company
Effective date
2019-07-22
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:54

Label at a glance#

ProductGuardian Loratadine
Active ingredientLORATADINE
Label structure15 sections

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

Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature] Protect from excessive moisture SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR PROTECTION" IS OPEN OR TORN 

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine USP, 10mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

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

.

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 DOCTOR IF

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

IF PREGNANT OR BREASTFEEDING,

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


 adults and children 6 years and over1 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

  • Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature]
  • Protect from excessive moisture


SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR PROTECTION" IS OPEN OR TORN 

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

call 1-609-860-2600 Hours: 8am-4pm, EST.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guardian
NDC 53041-285-21

Non-Drowsy*

Original Prescription Strength

Loratadine
Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat Or Nose



285
285

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311372loratadine 10 MG 24HR Oral TabletPSN1
311372loratadine 10 MG Oral TabletSCD1
311372loratadine 10 MG 24 HR Oral TabletSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53041-285-212022-01-28C16284748780-1d6a99b39-5077-a426-e053-dadaa90af4c2Guardian Loratadine Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-285-21Guardian Loratadine1000 in 1 BOTTLETABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-285GUARDIAN LORATADINE (LORATADINE) TABLET [GUARDIAN DRUG COMPANY]1Legacy NDC, 1 package rows20190723_af8cdd37-8fd0-4651-ae03-36c7d4863301.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
53041-28553041-285-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
A207569-001LORATADINELORATADINE10MGTABLET / ORAL2019-03-12

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 22:38:342026-08A207569-001LORATADINE10MGTABLET / ORAL2019-03-1284e616aacf4f…
2026-08-18 06:07:402026-07A207569-001LORATADINE10MGTABLET / ORAL2019-03-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207569-001LORATADINE10MGTABLET / ORAL2019-03-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207569-001LORATADINE10MGTABLET / ORAL2019-03-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A207569-001LORATADINE10MGTABLET / ORAL2019-03-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207569-001LORATADINE10MGTABLET / ORAL2019-03-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207569-001LORATADINE10MGTABLET / ORAL2019-03-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207569-001LORATADINE10MGTABLET / ORAL2019-03-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207569-001LORATADINE10MGTABLET / ORAL2019-03-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207569-001LORATADINE10MGTABLET / ORAL2019-03-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207569-001LORATADINE10MGTABLET / ORAL2019-03-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207569-001LORATADINE10MGTABLET / ORAL2019-03-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207569-001LORATADINE10MGTABLET / ORAL2019-03-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207569-001LORATADINE10MGTABLET / ORAL2019-03-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207569-001LORATADINE10MGTABLET / ORAL2019-03-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207569-001LORATADINE10MGTABLET / ORAL2019-03-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207569-001LORATADINE10MGTABLET / ORAL2019-03-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207569-001LORATADINE10MGTABLET / ORAL2019-03-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207569-001LORATADINE10MGTABLET / ORAL2019-03-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207569-001LORATADINE10MGTABLET / ORAL2019-03-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207569-001LORATADINE10MGTABLET / ORAL2019-03-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207569-001LORATADINE10MGTABLET / ORAL2019-03-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207569-001LORATADINE10MGTABLET / ORAL2019-03-1287673890dc5c…
2021-03-12 10:30 UTC2021-03A207569-001LORATADINE10MGTABLET / ORAL2019-03-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207569-001LORATADINE10MGTABLET / ORAL2019-03-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207569-001LORATADINE10MGTABLET / ORAL2019-03-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207569-001LORATADINE10MGTABLET / ORAL2019-03-123f01610625f2…
2019-09-15 20:21 UTC2019-09A207569-001LORATADINE10MGTABLET / ORAL2019-03-12b00525d2431f…
2019-07-19 19:46 UTC2019-07A207569-001LORATADINE10MGTABLET / ORAL2019-03-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207569-001LORATADINE10MGTABLET / ORAL2019-03-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207569-001LORATADINE10MGTABLET / ORAL2019-03-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207569-001LORATADINE10MGTABLET / ORAL2019-03-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207569-001LORATADINE10MGTABLET / ORAL2019-03-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207569-001LORATADINE10MGTABLET / ORAL2019-03-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207569-001LORATADINE10MGTABLET / ORAL2019-03-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207569-001LORATADINE10MGTABLET / ORAL2019-03-123f0d92c62455…
2023-05-13 08:27 UTC2023-05A207569-001LORATADINE10MGTABLET / ORAL2019-03-12053a50430f4f…
2023-01-26 05:58 UTC2023-01A207569-001LORATADINE10MGTABLET / ORAL2019-03-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207569-001LORATADINE10MGTABLET / ORAL2019-03-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207569-001LORATADINE10MGTABLET / ORAL2019-03-12f41ea6bd6efb…

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
af8cdd37-8fd0-4651-ae03-36c7d4863301af8cdd37-8fd0-4651-ae03-36c7d48633012019-07-22WarningsExact identifier
spl id: af8cdd37-8fd0-4651-ae03-36c7d4863301
spl set id: af8cdd37-8fd0-4651-ae03-36c7d4863301

Reported adverse events (FAERS/openFDA)#

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