Gencare-Allergy Relief Loratadine Tablets, 10 mg

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2025-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:06:14

Label at a glance#

ProductGencare-Allergy Relief Loratadine Tablets, 10 mg
Active ingredientLORATADINE
Label structure14 sections

Indications and uses

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)

Loratadine, 10 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms due to hay fever or other respiratory allergies:

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

Warnings

WARNINGS SECTION

Do not use if you ever have 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 take more than directed. Taking more than directed 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 pregnanct 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 (1-800-222-1222)

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

OTHER SAFETY INFORMATION

  • Store between 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature)
  •  Protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lactose monohydrate, magnesium stearate, povidone, maize starch, purified water.

OTC - QUESTIONS SECTION

Questions or comments?

Call: +1 (732) 994-2808 or email: support@gencare.health

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0269-00 GenCare Allergy Relief-Loratadine-300ctsPL0269-00 GenCare Allergy Relief-Loratadine-300cts

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-051-01Gencare-Allergy Relief Loratadine Tablets, 10 mg300 in 1 BOTTLETABLET3001

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
72090-05172090-051-01

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
A214684-001LORATADINELORATADINE10MGTABLET / ORAL2021-01-07

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 22:38:342026-08A214684-001LORATADINE10MGTABLET / ORAL2021-01-0784e616aacf4f…
2026-08-18 06:07:402026-07A214684-001LORATADINE10MGTABLET / ORAL2021-01-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214684-001LORATADINE10MGTABLET / ORAL2021-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A214684-001LORATADINE10MGTABLET / ORAL2021-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214684-001LORATADINE10MGTABLET / ORAL2021-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214684-001LORATADINE10MGTABLET / ORAL2021-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214684-001LORATADINE10MGTABLET / ORAL2021-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214684-001LORATADINE10MGTABLET / ORAL2021-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214684-001LORATADINE10MGTABLET / ORAL2021-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214684-001LORATADINE10MGTABLET / ORAL2021-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214684-001LORATADINE10MGTABLET / ORAL2021-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214684-001LORATADINE10MGTABLET / ORAL2021-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214684-001LORATADINE10MGTABLET / ORAL2021-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214684-001LORATADINE10MGTABLET / ORAL2021-01-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214684-001LORATADINE10MGTABLET / ORAL2021-01-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-075aa47cf7b7d7…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214684-001LORATADINE10MGTABLET / ORAL2021-01-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214684-001LORATADINE10MGTABLET / ORAL2021-01-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214684-001LORATADINE10MGTABLET / ORAL2021-01-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214684-001LORATADINE10MGTABLET / ORAL2021-01-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214684-001LORATADINE10MGTABLET / ORAL2021-01-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214684-001LORATADINE10MGTABLET / ORAL2021-01-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A214684-001LORATADINE10MGTABLET / ORAL2021-01-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A214684-001LORATADINE10MGTABLET / ORAL2021-01-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214684-001LORATADINE10MGTABLET / ORAL2021-01-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214684-001LORATADINE10MGTABLET / ORAL2021-01-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214684-001LORATADINE10MGTABLET / ORAL2021-01-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214684-001LORATADINE10MGTABLET / ORAL2021-01-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214684-001LORATADINE10MGTABLET / ORAL2021-01-07a50c72e98297…

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
Gencare-Allergy Relief Loratadine Tablets, 10 mgLORATADINEPioneer Life Sciences, LLC647dc957-4aee-48f6-bb77-e82d3b380e802025-06-30WarningsExact identifier
ndc (package): 72090-051-01
ndc (product): 72090-051
ndc11 (package): 72090005101
spl id: e45f0822-5a81-429b-9518-a9c423d6f9c3
spl set id: 647dc957-4aee-48f6-bb77-e82d3b380e80

Reported adverse events (FAERS/openFDA)#

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