Topcare Allergy Relief

Manufacturer
Topco Associates LLC
Effective date
2021-11-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:15

Label at a glance#

ProductTopcare Allergy Relief
Active ingredientLORATADINE
Label structure9 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

• 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

• do not use if printed blister unit is broken or torn • store between 20° to 25°C (68° to 77°F) • use tablet immediately after opening individual blister

Label contents#

Full prescribing information#

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
  • itchy, watery eyes
  • sneezing
  • 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 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 right away (1-800-222-1222).

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

  • do not use if printed blister unit is broken or torn
  • store between 20° to 25°C (68° to 77°F)
  • use tablet immediately after opening individual blister

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial mint flavor, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO CLARITIN® REDITABS® ACTIVE INGREDIENT†

NON-DROWSY*

ORIGINAL PRESCRIPTION STRENGTH

Allergy Relief

LORATADINE ORALLY DISINTEGRATING TABLETS, 10 mg – ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

● Sneezing

● Runny Nose

● Itchy, Watery Eyes

● Itchy Throat or Nose

No Water Needed

Melts in Your Mouth

30 TABLETS

*When taken as directed. See Drug Facts Panel.

actual size

5V988-allergy-relief
5V988-allergy-relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN3
311373loratadine 10 MG Disintegrating Oral TabletSCD3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-853-652021-12-01C16284748780-1c7ccaba7-14fa-fd44-e053-dadaa90aa01bTopco Associates LLC. Allergy Relief Drug Facts
36800-853-652021-07-23C16284748780-1c7ccaba7-14fa-fd44-e053-dadaa90aa01bTopco Associates LLC. Allergy Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-853-65Topcare Allergy Relief30 in 1 CARTONTABLET, ORALLY DISINTEGRATING303
36800-853-65Topcare Allergy Relief1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-853TOPCARE ALLERGY RELIEF (LORATADINE) TABLET, ORALLY DISINTEGRATING [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20211202_32f4e1d1-c830-4752-8251-bcc233bf03f6.zip

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
36800-85336800-853-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
A076011-001LORATADINELORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29

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 22:38:342026-08A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2984e616aacf4f…
2026-08-18 06:07:402026-07A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-293f01610625f2…
2019-09-15 20:21 UTC2019-09A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076011-001LORATADINE10MGTABLET, ORALLY DISINTEGRATING / ORAL2003-09-29f41ea6bd6efb…

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
Topcare Allergy ReliefLORATADINETopco Associates LLC32f4e1d1-c830-4752-8251-bcc233bf03f62021-11-29WarningsExact identifier
ndc (package): 36800-853-65
ndc (product): 36800-853
ndc11 (package): 36800085365
spl id: 4bd57bff-c68b-497f-801d-e60d9c7b8390
spl set id: 32f4e1d1-c830-4752-8251-bcc233bf03f6

Reported adverse events (FAERS/openFDA)#

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