topcare all day allergy

Manufacturer
Topco Associates LLC
Effective date
2023-02-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:54:27

Label at a glance#

Producttopcare all day allergy
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

• avoid high humidity and excessive heat above 40°C (104°F) • protect from light

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 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
  • 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 or to an antihistamine containing hydroxyzine.

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.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking tranquilizers or sedatives.

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

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 and children 6 years and over

one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, gelatin, glycerin, mannitol, may contain pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare® health

COMPARE TO ZYRTEC® LIQUID GELS ACTIVE INGREDIENT

ORIGINAL PRESCRIPTION STRENGTH

All Day Allergy

CETIRIZINE HYDROCHLORIDE CAPSULES 10 mg

ANTIHISTAMINE

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

65 LIQUID GELS**

actual size

** LIQUID FILLED CAPSULES

all day allergy image
all day allergy image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN3
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD3
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-448-09topcare all day allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED13
36800-448-09topcare all day allergy65 in 1 BOTTLECAPSULE, LIQUID FILLED653
36800-448-49topcare all day allergy40 in 1 BOTTLECAPSULE, LIQUID FILLED403
36800-448-49topcare all day allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED13
36800-448-63topcare all day allergy25 in 1 BOTTLECAPSULE, LIQUID FILLED253
36800-448-63topcare all day allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-448TOPCARE ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 6 package rows20230314_10c512a1-bb96-4d2a-9e41-a422efb57e28.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-44836800-448-63, 36800-448-09, 36800-448-49

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
A213105-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2020-09-21

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 22:38:342026-08A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2184e616aacf4f…
2026-08-18 06:07:402026-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-214b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21a50c72e98297…

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 allergyCETIRIZINE HYDROCHLORIDETopco Associates LLC10c512a1-bb96-4d2a-9e41-a422efb57e282023-02-09WarningsExact identifier
ndc (package): 36800-448-09
ndc (package): 36800-448-49
ndc (package): 36800-448-63
ndc (product): 36800-448
ndc11 (package): 36800044849
ndc11 (package): 36800044863
ndc11 (package): 36800044809
spl id: eb748140-aec8-4fcf-9597-20610d87635a
spl set id: 10c512a1-bb96-4d2a-9e41-a422efb57e28

Reported adverse events (FAERS/openFDA)#

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