Childrens Zyrtec Allergy

Manufacturer: Kenvue Brands LLC
Effective date: 2026-01-19
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 01:34:31

Label at a glance#

ProductChildrens Zyrtec Allergy

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

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 d...

Storage and handling

store between 20° to 25°C (68° to 77°F) do not use if carton is opened. Do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing see bottom panel for lot number and expiration date

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 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

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.

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
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

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. Do not use if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing
see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate, sorbitol solution, 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

NDC 50580-721-05

Children's
ZYRTEC ^®
ALLERGY

Cetirizine HCl oral solution
1 mg / ml/ antihistamine

Indoor & Outdoor Allergies

2 yrs & older

24 Hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Dye-Free

Sugar-Free

Alcohol-Free

Bubble Gum Flavor

4 fl oz (118 ml)

Dosing Cup Included

zyrtec-1.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	10
1020021	ZyrTEC 5 MG in 5 mL Oral Solution	PSN	10
1020021	cetirizine hydrochloride 1 MG/ML Oral Solution [Zyrtec]	SBD	10
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	10
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	10
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	10
1020021	Children's Zyrtec 5 MG per 5 ML Medicated Spoon	SY	10
1020021	Zyrtec 1 MG/ML Oral Solution	SY	10
1020021	Zyrtec Children's 5 MG per 5 ML Syrup	SY	10

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
50580-721-05	Childrens Zyrtec Allergy	118 mL in 1 BOTTLE, PLASTIC	SYRUP	118		10
50580-721-05	Childrens Zyrtec Allergy	1 in 1 CARTON	SYRUP	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-721-04	ML - Milliliter	50580-721	f9512a1d-f76a-4184-baea-882afa736081	1	2015-10-02
50580-721-05	ML - Milliliter	50580-721	17d2c830-f0df-412d-9d9a-81798d1a957a	1	2017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Cetirizine Hydrochloride	ACTIVE INGREDIENT	64O047KTOA	2
Cetirizine	ACTIVE MOIETY	YO7261ME24	2
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	2
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	2
sorbitol	INACTIVE INGREDIENT	506T60A25R	2
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	2
water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Childrens Zyrtec Allergy
Cetirizine Hydrochloride
SORBITOL SOLUTION
ANHYDROUS CITRIC ACID
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
SUCRALOSE
CETIRIZINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-721	50580-721-05

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
SORBITOL SOLUTION	8KW3E207O2	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
CETIRIZINE HYDROCHLORIDE	64O047KTOA	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
9	2025-10-10	monthly-update	2026-06-03 17:39:14
8	2025-05-07	full-release	2026-06-01 01:01:02

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 ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sucralose	SUCRALOSE	96K6UQ3ZD4	SYRUP / ORAL		80 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact 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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022155-001	CHILDREN'S ZYRTEC HIVES	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD, RS	2007-11-16
N022155-002	CHILDREN'S ZYRTEC ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG/5ML	SOLUTION / ORAL		RLD, RS	2007-11-16

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022155-001	CHILDREN'S ZYRTEC HIVES	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SOLUTION / ORAL	RLD, RS	2007-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022155-001	CHILDREN'S ZYRTEC HIVES RELIEF	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022155-002	CHILDREN'S ZYRTEC ALLERGY	5MG/5ML	SYRUP / ORAL	RLD, RS	2007-11-16	`4b0b4de00fa7…`

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
Childrens Zyrtec Allergy	CETIRIZINE HYDROCHLORIDE	Kenvue Brands LLC	ee8695ac-1293-4e43-ac7c-a64e21a0ca0a	2026-01-19	Warnings	Exact identifier ndc (package): 50580-721-05 ndc (product): 50580-721 ndc11 (package): 50580072105 spl id: 48bb7dd3-c2b8-ecfb-e063-6294a90af77d spl set id: ee8695ac-1293-4e43-ac7c-a64e21a0ca0a

Reported adverse events (FAERS/openFDA)#

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