Topcare All Day Allergy

Manufacturer
Topco Associates LLC
Effective date
2022-02-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:48:36

Label at a glance#

ProductTopcare All Day Allergy
Active ingredientLEVOCETIRIZINE DIHYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Dosage and administration

adults 65 years of age and older • ask a doctor adults and children 12-64 years of age • take 1 tablet (5 mg) once daily in the evening • do not take more than 1 tablet (5 mg) in 24 hours • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age • take ½ tablet (2.5 mg) once daily in the evening • do not take more than ½ tablet (2.5 mg) in 24 hours childre...

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Levocetirizine dihydrochloride 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other 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 kidney disease
  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • ever had trouble urinating or emptying your bladder

When using this product

OTC - WHEN USING SECTION

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have trouble urinating or emptying your bladder
  • an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • if breast-feeding: not recommended
  • if pregnant: 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

adults 65 years of age and older

  • ask a doctor

adults and children 12-64 years of age

  • take 1 tablet (5 mg) once daily in the evening
  • do not take more than 1 tablet (5 mg) in 24 hours
  • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms

children 6-11 years of age

  • take ½ tablet (2.5 mg) once daily in the evening
  • do not take more than ½ tablet (2.5 mg) in 24 hours

children under 6 years of age

  • do not use

consumers with kidney disease

  • do not use

Other information

OTHER SAFETY INFORMATION

  • store between 20° and 25°C (68° and 77°F)
  • do not use if blister unit is broken or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare® health

COMPARE TO XYZAL® ALLERGY 24HR ACTIVE INGREDIENT

ORIGINAL PRESCRIPTION STRENGTH

All Day Allergy

LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS, 5 mg

ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

• Sneezing • Runny Nose

• Itchy Nose or throat

• Itchy, Watery Eyes

10 TABLETS

actual size

all day allergy image
all day allergy image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN4
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD4
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LEVOCETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-241-01Topcare All Day Allergy35 in 1 BOTTLETABLET, FILM COATED354
36800-241-01Topcare All Day Allergy1 in 1 CARTONTABLET, FILM COATED14
36800-241-46Topcare All Day Allergy10 in 1 CARTONTABLET, FILM COATED104
36800-241-46Topcare All Day Allergy1 in 1 BLISTER PACKTABLET, FILM COATED14
36800-241-95Topcare All Day Allergy45 in 1 BOTTLETABLET, FILM COATED454
36800-241-95Topcare All Day Allergy1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-241TOPCARE ALL DAY ALLERGY (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 6 package rows20220305_393616df-52f1-4e77-b69c-8239ca193d5b.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
36800-24136800-241-01, 36800-241-46, 36800-241-95

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML · Source PDF

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
A211983-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28

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 22:38:342026-08A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28f41ea6bd6efb…

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 All Day AllergyLEVOCETIRIZINE DIHYDROCHLORIDETopco Associates LLC393616df-52f1-4e77-b69c-8239ca193d5b2022-02-21WarningsExact identifier
ndc (package): 36800-241-01
ndc (package): 36800-241-95
ndc (package): 36800-241-46
ndc (product): 36800-241
ndc11 (package): 36800024195
ndc11 (package): 36800024146
ndc11 (package): 36800024101
spl id: e685d7d8-ba5f-424a-9a98-54bde72bfacf
spl set id: 393616df-52f1-4e77-b69c-8239ca193d5b

Reported adverse events (FAERS/openFDA)#

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