FDA.reportPublic FDA data

Cetirizine Hydrochloride Chewable Tablets

Manufacturer
Novel Laboratories, Inc.
Effective date
2019-12-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:02:14

Label at a glance#

ProductCetirizine Hydrochloride
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure14 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 For Cetirizine Hydrochloride Chewable Tablets, 5 mg adults and children 6 years 1 to 2 tablets once daily depending upon severity of symptoms; do not take and over more than 2 tablets in 24 hours. adults 65 years and over 1 tablet once a day; do not take more than 1 tablet in 24 hours children under 6 years of ask a doctor age consumers with liver or ask a doctor kidney disease F...

Label contents#

Full prescribing information#

Active Ingredient in each chewable tablet

OTC - ACTIVE INGREDIENT SECTION

For 5 mg:

Cetirizine hydrochloride 5 mg

For 10 mg:

Cetirizine hydrochloride 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 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

For Cetirizine Hydrochloride Chewable Tablets, 5 mg

adults and children 6 years
1 to 2 tablets once daily depending upon severity of symptoms; do not take
and over
more than 2 tablets in 24 hours.
adults 65 years and over
1 tablet once a day; do not take more than 1 tablet in 24 hours


children under 6 years of
ask a doctor
age

consumers with liver or
ask a doctor
kidney disease

For Cetirizine Hydrochloride Chewable Tablets, 10 mg

adults and children 6
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A
years and over
5 mg product may be appropriate for less severe symptoms.
adults 65 years and
ask a doctor
over

children under 6 years of age
ask a doctor
consumers with liver
ask a doctor
or kidney disease

Other 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

Call 1-866-403-7592

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

For 5 mg Allergy:

NDC 40032-653-03

Children's

Cetirizine Hydrochloride Chewable Tablets

5 mg

ALLERGY

Antihistamine

Indoor & Outdoor Allergies

Tutti-frutti Flavor

6 yrs. & older

30 CHEWABLE TABLETS

Container Label

C:\Users\kvyas\Desktop\Cetirizine HCL\container 1.jpg
C:\Users\kvyas\Desktop\Cetirizine HCL\container 1.jpg
C:\Users\kvyas\Desktop\Cetirizine HCL\container 2.jpg
C:\Users\kvyas\Desktop\Cetirizine HCL\container 2.jpg
C:\Users\kvyas\Desktop\Cetirizine HCL\container 3.jpg
C:\Users\kvyas\Desktop\Cetirizine HCL\container 3.jpg

Container Carton

C:\Users\kvyas\Desktop\Cetirizine HCL\container carton.jpg
C:\Users\kvyas\Desktop\Cetirizine HCL\container carton.jpg

For 10 mg Allergy:

NDC 40032-652-31

Children's

Cetirizine Hydrochloride Chewable Tablets

10 mg

ALLERGY

Antihistamine

Indoor & Outdoor Allergies

Tutti-frutti Flavor

6 yrs. & older

Blister Label

C:\Users\kvyas\Desktop\Cetirizine HCL\blister.jpg
C:\Users\kvyas\Desktop\Cetirizine HCL\blister.jpg

Blister Carton

NDC 40032-652-30

C:\Users\kvyas\Desktop\Cetirizine HCL\blistercarton front.jpg
C:\Users\kvyas\Desktop\Cetirizine HCL\blistercarton front.jpg
C:\Users\kvyas\Desktop\Cetirizine HCL\blistercarton back.jpg
C:\Users\kvyas\Desktop\Cetirizine HCL\blistercarton back.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014674cetirizine HCl 10 MG Chewable TabletPSN4
1014643cetirizine HCl 5 MG Chewable TabletPSN4
1014674cetirizine hydrochloride 10 MG Chewable TabletSCD4
1014643cetirizine hydrochloride 5 MG Chewable TabletSCD4

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
40032-652-032025-01-30C16284748780-12cef2736-5b0a-d83d-e063-dadaa90ab31fCetirizine Hydrochloride Chewable Tablets
40032-652-102025-01-30C16284748780-12cef2736-5b0a-d83d-e063-dadaa90ab31fCetirizine Hydrochloride Chewable Tablets
40032-652-302025-01-30C16284748780-12cef2736-5b0a-d83d-e063-dadaa90ab31fCetirizine Hydrochloride Chewable Tablets
40032-653-032025-01-30C16284748780-12cef2736-5b0a-d83d-e063-dadaa90ab31fCetirizine Hydrochloride Chewable Tablets
40032-653-102025-01-30C16284748780-12cef2736-5b0a-d83d-e063-dadaa90ab31fCetirizine Hydrochloride Chewable Tablets
40032-653-302025-01-30C16284748780-12cef2736-5b0a-d83d-e063-dadaa90ab31fCetirizine Hydrochloride Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-652-03Cetirizine Hydrochloride1 in 1 CARTONTABLET, CHEWABLE14
40032-652-03Cetirizine Hydrochloride30 in 1 BOTTLETABLET, CHEWABLE304
40032-652-10Cetirizine Hydrochloride1000 in 1 BOTTLETABLET, CHEWABLE10004
40032-652-30Cetirizine Hydrochloride10 in 1 BLISTER PACKTABLET, CHEWABLE104
40032-652-30Cetirizine Hydrochloride3 in 1 CARTONTABLET, CHEWABLE34
40032-653-03Cetirizine Hydrochloride30 in 1 BOTTLETABLET, CHEWABLE304
40032-653-03Cetirizine Hydrochloride1 in 1 CARTONTABLET, CHEWABLE14
40032-653-10Cetirizine Hydrochloride1000 in 1 BOTTLETABLET, CHEWABLE10004
40032-653-30Cetirizine Hydrochloride3 in 1 CARTONTABLET, CHEWABLE34
40032-653-30Cetirizine Hydrochloride10 in 1 BLISTER PACKTABLET, CHEWABLE104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-652CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.]4Legacy NDC, 5 package rows20191221_c6a339dc-d56a-49d9-bf74-af54d2ba9b3c.zip
40032-653CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.]4Legacy NDC, 5 package rows20191221_c6a339dc-d56a-49d9-bf74-af54d2ba9b3c.zip

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
40032-65340032-653-10, 40032-653-30, 40032-653-03
40032-65240032-652-30, 40032-652-10, 40032-652-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED2165RE0K14IACT
POLACRILINRCZ785HI7SIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
MAGNESIUM STEARATE70097M6I30IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED2165RE0K14IACT
POLACRILINRCZ785HI7SIACT
ACESULFAME POTASSIUM23OV73Q5G9IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
MAGNESIUM STEARATE70097M6I30IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB

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
9a2d773a-3076-84c5-e053-2995a90a5864c6a339dc-d56a-49d9-bf74-af54d2ba9b3c2019-12-20WarningsExact identifier
spl id: 9a2d773a-3076-84c5-e053-2995a90a5864
spl set id: c6a339dc-d56a-49d9-bf74-af54d2ba9b3c

Reported adverse events (FAERS/openFDA)#

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