Zyrtec Allergy

Manufacturer: Kenvue Brands LLC
Effective date: 2026-04-27
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 01:55:29

Label at a glance#

ProductZyrtec

Active ingredientCETIRIZINE HYDROCHLORIDE

Label structure10 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 chew or crush tablets completely before swallowing adults and children 6 years and over Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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

store between 20° to 25°C (68° to 77°F) do not use if blister unit is torn or broken

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-343-7805

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

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

Warnings

OTC - DO NOT USE 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

OTC - WHEN USING SECTION

When using this product

drowsiness may occur
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

OTC - STOP USE SECTION

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding:

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

may be taken with or without water

chew or crush tablets completely before swallowing

adults and children 6 years and over	Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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

store between 20° to 25°C (68° to 77°F)
do not use if blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

betadex, corn starch, lactose monohydrate, magnesium stearate, mannitol, silicified microcrystalline cellulose, sucralose

Questions?

OTC - QUESTIONS SECTION

call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 50580-753-24

ZYRTEC ^®

Cetirizine HCl Chewable tablets,
10 mg /antihistamine

ALLERGY

Indoor +

Outdoor

Allergies

10 mg Strength Tablets

Dye-Free

CHEWABLES

24 HOUR

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Actual Size

No Water Needed

Chew or crush tablets

completely before swallowing

24 CHEWABLE TABLETS

Zyrtec-1.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014674	cetirizine HCl 10 MG Chewable Tablet	PSN	9
1020022	ZyrTEC 10 MG Chewable Tablet	PSN	9
1020022	cetirizine hydrochloride 10 MG Chewable Tablet [Zyrtec]	SBD	9
1014674	cetirizine hydrochloride 10 MG Chewable Tablet	SCD	9
1020022	Zyrtec 10 MG Chewable Tablet	SY	9

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0300450250247	GTIN-13: 0300450250247 EAN-13: 0300450250247 GTIN-12: 300450250247 UPC-A: 300450250247 GTIN storage (14 digits): 00300450250247	Zyrtec-1.jpg
Data code	Code 128	30061347		Zyrtec-1.jpg

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
50580-753-24	Zyrtec	6 in 1 BLISTER PACK	TABLET, CHEWABLE	6		9
50580-753-24	Zyrtec	4 in 1 CARTON	TABLET, CHEWABLE	4		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-753-24	EA - Each	50580-753	26d4a533-ec51-4738-b3bb-607771ccf9c4	1	2022-08-04

Products#

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

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

Zyrtec
Cetirizine Hydrochloride
BETADEX
STARCH, CORN
MAGNESIUM STEARATE
MANNITOL
SUCRALOSE
CETIRIZINE
LACTOSE MONOHYDRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-753	50580-753-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BETADEX	JV039JZZ3A	IACT
STARCH, CORN	O8232NY3SJ	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT

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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021621-003	CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16
N021621-004	CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16
N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16
N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16
N021621-007	CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30

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 6 · 209 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021621-003	CHILDREN'S ZYRTEC ALLERGY	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021621-004	CHILDREN'S ZYRTEC ALLERGY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021621-005	CHILDREN'S ZYRTEC HIVES RELIEF	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021621-006	CHILDREN'S ZYRTEC HIVES RELIEF	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021621-007	CHILDREN'S ZYRTEC ALLERGY	2.5MG	TABLET, CHEWABLE / ORAL	RLD	2020-11-30	`03ed91905a0d…`

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
Zyrtec	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	dc613bd5-70fd-1d9b-e053-2995a90a41cd	2026-04-27	Warnings	Exact identifier ndc (package): 50580-753-24 ndc (product): 50580-753 ndc11 (package): 50580075324 spl id: 506ace58-15cc-77b4-e063-6394a90a0813 spl set id: dc613bd5-70fd-1d9b-e053-2995a90a41cd

Reported adverse events (FAERS/openFDA)#

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