Equate Cetirizine Hydrochloride Chewable Tablets 10 mg

Manufacturer
Wal-Mart Stores, Inc. | Novel Laboratories, Inc.
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:56

Label at a glance#

ProductCetirizine Hydrochloride
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure15 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

may be taken with or without water Adults and children 6 years and over One 10 mg tablet once daily; do not take more than one 10 mg tablet 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

Label contents#

Full prescribing information#

Active Ingredient in each chewable tablet

OTC - ACTIVE INGREDIENT SECTION

Cetirizine Hydrochloride Chewable Tablets 10mg

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 if you have ever had an allergic reactions 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

OTC - ASK DOCTOR/PHARMACIST SECTION

if you are 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 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 the 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 at (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • may be taken with or without water
Adults and children 6 years and over
One 10 mg tablet once daily; do not take more than one 10 mg tablet 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

OTHER SAFETY INFORMATION

  • store between 20° to 25°C (68° to 77°F)
  • Do not use if individual blister unit is open or torn

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, colloidal silicon dioxide, D&C YELLOW # 10, FD&C RED # 40, FD&C YELLOW # 6, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polacrilex resin, sodium starch glycolate, sucralose and tutti frutti flavor

QUESTIONS

OTC - QUESTIONS SECTION

1-888-287-1915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blister
Blister
carton
carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014674cetirizine HCl 10 MG Chewable TabletPSN1
1014674cetirizine hydrochloride 10 MG Chewable TabletSCD1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-652-242020-01-31C16284748780-19d75b9d0-c3eb-f424-e053-dadaa90a57ceEquate Cetirizine Hydrochloride Chewable Tablets 10 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-652-24Cetirizine Hydrochloride4 in 1 CARTONTABLET, CHEWABLE41
49035-652-25Cetirizine Hydrochloride6 in 1 BLISTER PACKTABLET, CHEWABLE61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-652CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [WAL-MART STORES, INC.]1Legacy NDC, 2 package rows20181222_fcc77bdc-5fcc-43c1-be0d-1827eebccf35.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-652-24EA - Each49035-65265fae259-1451-42f2-94e2-ad1447fdb8cd12024-01-04

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-65249035-652-25, 49035-652-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORAL2016-03-08
A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORAL2016-03-08

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-0884e616aacf4f…
2026-09-14 22:38:342026-08A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-0884e616aacf4f…
2026-08-18 06:07:402026-07A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206793-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2016-03-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206793-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2016-03-0874a2ff9319b5…

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
f5eb545f-57f8-42f5-b9d9-ee3b14661444fcc77bdc-5fcc-43c1-be0d-1827eebccf352018-12-21WarningsExact identifier
spl id: f5eb545f-57f8-42f5-b9d9-ee3b14661444
spl set id: fcc77bdc-5fcc-43c1-be0d-1827eebccf35

Reported adverse events (FAERS/openFDA)#

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