Topcare Childrens All Day Allergy

Manufacturer
Topco Associates LLC
Effective date
2019-11-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:01:47

Label at a glance#

ProductTopcare Childrens All Day Allergy
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure8 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

• use only with enclosed dosing cup • find right dose on chart below • mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL ...

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl 5 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

  • use only with enclosed dosing cup
  • find right dose on chart below
  • mL = milliliter

adults and children

6 years and over

5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.

adults 65 years

and over

5 mL once daily; do not take more than 5 mL in 24 hours.

children 2 to under

6 years of age

2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.

children under

2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened, or if printed neckband is broken or missing
  • see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO CHILDREN’S ZYRTEC® ACTIVE INGREDIENT

children’s

All-Day Allergy

CETIRIZINE HYDROCHLORIDE ORAL SOLUTION 1 mg / mL

ANTIHISTAMINE

OUR PHARMACISTS RECOMMEND

INDOOR & OUTDOOR ALLERGIES

24 HOUR

RELIEF OF:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Dye Free & Sugar Free

2 Years & older

BUBBLE GUM FLAVOR

4 FL OZ (118 mL)

Dosing cup included

189-88-childrens-all-day-allergy.jpg
189-88-childrens-all-day-allergy.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN4
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD4
1014673cetirizine HCl 1 MG/ML Oral SyrupSY4
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-189-26Topcare Childrens All Day Allergy118 mL in 1 BOTTLESOLUTION1184
36800-189-26Topcare Childrens All Day Allergy1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-189TOPCARE CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 2 package rows20191206_d29e50bc-75fe-437e-98a5-e0446919fcd6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-189-26ML - Milliliter36800-1899d601c8f-4482-46ab-8bae-ccc23a77f90612018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOA1
CETIRIZINEACTIVE MOIETYYO7261ME241
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-18936800-189-26

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / ORAL3900 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2013-09-09

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 22:38:342026-08A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-0984e616aacf4f…
2026-08-18 06:07:402026-07A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-093f01610625f2…
2019-09-15 20:21 UTC2019-09A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSOLUTION / ORAL2013-09-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204226-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLSYRUP / ORAL2013-09-09f41ea6bd6efb…

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 Childrens All Day AllergyCETIRIZINE HCLTopco Associates LLCd29e50bc-75fe-437e-98a5-e0446919fcd62019-11-21WarningsExact identifier
ndc (package): 36800-189-26
ndc (product): 36800-189
ndc11 (package): 36800018926
spl id: 15730e7e-0610-4e21-af6c-098f6615dd21
spl set id: d29e50bc-75fe-437e-98a5-e0446919fcd6

Reported adverse events (FAERS/openFDA)#

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