ZYRTEC HIVES

Manufacturer
Kenvue Brands LLC
Effective date
2025-06-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:03:12

Label at a glance#

ProductZYRTEC HIVES
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

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

Storage and handling

Other information ■ store between 20° to 25°C (68° to 77°F) ■ do not use if carton is opened or if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCI 5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

WARNINGS SECTION

Severe Allergy Warning

SPL UNCLASSIFIED SECTION

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the
following symptoms:
■ trouble swallowing
■ dizziness or loss of consciousness
■ swelling of tongue
■ swelling in or around mouth
■ trouble speaking
■ drooling
■ wheezing or problems breathing
These symptoms may be signs of anaphylactic shock.
This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for anaphylaxis or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

OTC - DO NOT USE SECTION

■ to prevent hives from any known cause such as:
■ foods
■ insect stings
■ medicines
■ latex or rubber gloves
because this product will not stop hives from occurring. Avoiding the cause of your hives is the only
way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives,
see your doctor for a medical exam. Your doctor may be able to help you find a cause.
■ 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.
■ hives that are an unusual color, look bruised or blistered
■ hives that do not itch

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

OTC - STOP USE SECTION

Stop use and ask a doctor if
■ an allergic reaction to this product occurs. Seek medical help right away.
■ symptoms do not improve after 3 days of treatment
■ the hives have lasted more than 6 weeks

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 under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

STORAGE AND HANDLING SECTION

Other information
■ store between 20° to 25°C (68° to 77°F)

■ do not use if carton is opened or if bottle wrap imprinted with “Sealed For Your Safety” is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION


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

Questions?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-128-04

Children’s

ZYRTEC®HIVES

Cetirizine HCl oral solution
1 mg/ml/antihistamine

Hives Relief

6 yrs & old

HIVES RELIEF

24 Hour relief

Reduces Itching Due to Hives

Reduces Hives

Grape Flavor

4 fl oz (118ml)

Dosing cup included

zyrtec_1 .jpgzyrtec_1 .jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN2
1020021ZyrTEC 5 MG in 5 mL Oral SolutionPSN2
1020021cetirizine hydrochloride 1 MG/ML Oral Solution [Zyrtec]SBD2
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD2
1014673cetirizine HCl 1 MG/ML Oral SyrupSY2
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY2
1020021Children's Zyrtec 5 MG per 5 ML Medicated SpoonSY2
1020021Zyrtec 1 MG/ML Oral SolutionSY2
1020021Zyrtec Children's 5 MG per 5 ML SyrupSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-128-04ZYRTEC HIVES1 in 1 CARTONSOLUTION12
50580-128-04ZYRTEC HIVES118 mL in 1 BOTTLESOLUTION1182

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-12850580-128-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
N022155-001CHILDREN'S ZYRTEC HIVESCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD, RS2007-11-16
N022155-002CHILDREN'S ZYRTEC ALLERGYCETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD, RS2007-11-16

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-1684e616aacf4f…
2026-08-18 06:07:402026-07N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022155-001CHILDREN'S ZYRTEC HIVES5MG/5MLSOLUTION / ORALRLD, RS2007-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSOLUTION / ORALRLD, RS2007-11-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSOLUTION / ORALRLD, RS2007-11-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSYRUP / ORALRLD, RS2007-11-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSYRUP / ORALRLD, RS2007-11-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSYRUP / ORALRLD, RS2007-11-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSYRUP / ORALRLD, RS2007-11-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSYRUP / ORALRLD, RS2007-11-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSYRUP / ORALRLD, RS2007-11-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022155-001CHILDREN'S ZYRTEC HIVES RELIEF5MG/5MLSYRUP / ORALRLD, RS2007-11-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022155-002CHILDREN'S ZYRTEC ALLERGY5MG/5MLSYRUP / ORALRLD, RS2007-11-1674a2ff9319b5…

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
ZYRTEC HIVESCETIRIZINE HYDROCHLORIDEKenvue Brands LLC31400cb2-fe85-ef74-e063-6294a90a11fb2025-06-16WarningsExact identifier
ndc (package): 50580-128-04
ndc (product): 50580-128
ndc11 (package): 50580012804
spl id: 37b3c47a-f31a-20f4-e063-6294a90ab07a
spl set id: 31400cb2-fe85-ef74-e063-6294a90a11fb

Reported adverse events (FAERS/openFDA)#

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