Cetirza

Manufacturer: HART Health
Effective date: 2025-10-06
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:37:59

Label at a glance#

ProductCetirza

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 12 years and over: Take one tablet once daily Do not take more than one tablet in 24 hours. Children under 12 years of age: ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

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 if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine

Ask doctor if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease.

Ask doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

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

OTC - STOP USE SECTION

if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 12 years and over:

Take one tablet once daily
Do not take more than one tablet in 24 hours.

Children under 12 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

do not use if blister unit is broken or torn
store at 59° to 86°F (15°-30°C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5694 Cetirza box v25b_Final_Small_Jpeg.jpg5694 Cetirza box v25b_Final_Small_Jpeg.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014678	cetirizine HCl 10 MG Oral Tablet	PSN	1
1014678	cetirizine hydrochloride 10 MG Oral Tablet	SCD	1
1014678	cetirizine HCl 10 MG Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CETIRIZINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50332-0154-2	Cetirza	3 in 1 BOX	TABLET	3		1
50332-0154-2	Cetirza	10 in 1 BLISTER PACK	TABLET	10		1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Cetirza
Cetirizine HCl
CETIRIZINE HYDROCHLORIDE
CETIRIZINE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50332-0154	50332-0154-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIM
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirza	CETIRIZINE HCL	HART Health	44b22f6f-5731-4dfe-af33-4e4e54fc3af5	2025-10-06	Warnings	Exact identifier ndc (package): 50332-0154-2 ndc (product): 50332-0154 ndc11 (package): 50332015402 spl id: 15856075-56a8-479d-ae9a-ebd9477faee8 spl set id: 44b22f6f-5731-4dfe-af33-4e4e54fc3af5

Reported adverse events (FAERS/openFDA)#

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