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

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet 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

Other information store between 20° to 25°C (68° to 77°F) do not use if foil inner seal imprinted with “Sealed For Your Safety” is broken or missing meets USP Dissolution Test 2

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

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

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

Other information

  • store between 20° to 25°C (68° to 77°F)
  • do not use if foil inner seal imprinted with “Sealed For Your Safety” is broken or missing
  • meets USP Dissolution Test 2

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Original Prescription Strength

NDC 50580-116-30

ZYRTEC ® HIVES
Cetirizine HCl tablets
10mg/antihistamine

Hives Relief

24 Hour relief

Reduces Hives

Reduces Itching Due to Hives

30 Tablets 10 mg each

Actual Size

30 TABLETS

zyrtec-1.jpgzyrtec-1.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN2
1020026ZyrTEC 10 MG Oral TabletPSN2
1020026cetirizine hydrochloride 10 MG Oral Tablet [Zyrtec]SBD2
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2
1014678cetirizine HCl 10 MG Oral TabletSY2
1020026Zyrtec (cetirizine dihydrochloride 10 MG) Oral TabletSY2
1020026Zyrtec 10 MG Oral TabletSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-116-30ZYRTEC Hives30 in 1 BOTTLETABLET, FILM COATED302
50580-116-30ZYRTEC Hives1 in 1 CARTONTABLET, FILM COATED12

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-11650580-116-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019835-003ZYRTEC ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORALRLD2007-11-16
N019835-004ZYRTEC ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORALRLD, RS2007-11-16
N019835-005ZYRTEC HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORALRLD2007-11-16
N019835-006ZYRTEC HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORALRLD2007-11-16

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019835-003ZYRTEC ALLERGY5MGTABLET / ORALRLD2007-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N019835-004ZYRTEC ALLERGY10MGTABLET / ORALRLD, RS2007-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N019835-005ZYRTEC HIVES5MGTABLET / ORALRLD2007-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N019835-006ZYRTEC HIVES10MGTABLET / ORALRLD2007-11-1684e616aacf4f…
2026-08-18 06:07:402026-07N019835-003ZYRTEC ALLERGY5MGTABLET / ORALRLD2007-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07N019835-004ZYRTEC ALLERGY10MGTABLET / ORALRLD, RS2007-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07N019835-005ZYRTEC HIVES5MGTABLET / ORALRLD2007-11-16caaa826d4ba7…
2026-08-18 06:07:402026-07N019835-006ZYRTEC HIVES10MGTABLET / ORALRLD2007-11-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019835-003ZYRTEC ALLERGY5MGTABLET / ORALRLD2007-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019835-004ZYRTEC ALLERGY10MGTABLET / ORALRLD, RS2007-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019835-005ZYRTEC HIVES5MGTABLET / ORALRLD2007-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019835-006ZYRTEC HIVES10MGTABLET / ORALRLD2007-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019835-003ZYRTEC ALLERGY5MGTABLET / ORALRLD2007-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019835-004ZYRTEC ALLERGY10MGTABLET / ORALRLD, RS2007-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019835-005ZYRTEC HIVES5MGTABLET / ORALRLD2007-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019835-006ZYRTEC HIVES10MGTABLET / ORALRLD2007-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N019835-003ZYRTEC ALLERGY5MGTABLET / ORALRLD2007-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019835-004ZYRTEC ALLERGY10MGTABLET / ORALRLD, RS2007-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019835-005ZYRTEC HIVES5MGTABLET / ORALRLD2007-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019835-006ZYRTEC HIVES10MGTABLET / ORALRLD2007-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019835-003ZYRTEC ALLERGY5MGTABLET / ORALRLD2007-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019835-004ZYRTEC ALLERGY10MGTABLET / ORALRLD, RS2007-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019835-005ZYRTEC HIVES5MGTABLET / ORALRLD2007-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019835-006ZYRTEC HIVES10MGTABLET / ORALRLD2007-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019835-003ZYRTEC ALLERGY5MGTABLET / ORALRLD2007-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019835-004ZYRTEC ALLERGY10MGTABLET / ORALRLD, RS2007-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019835-005ZYRTEC HIVES5MGTABLET / ORALRLD2007-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019835-006ZYRTEC HIVES10MGTABLET / ORALRLD2007-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019835-003ZYRTEC ALLERGY5MGTABLET / ORALRLD2007-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019835-004ZYRTEC ALLERGY10MGTABLET / ORALRLD, RS2007-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019835-005ZYRTEC HIVES5MGTABLET / ORALRLD2007-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019835-006ZYRTEC HIVES10MGTABLET / ORALRLD2007-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019835-003ZYRTEC ALLERGY5MGTABLET / ORALRLD2007-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019835-004ZYRTEC ALLERGY10MGTABLET / ORALRLD, RS2007-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019835-005ZYRTEC HIVES RELIEF5MGTABLET / ORALRLD2007-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019835-006ZYRTEC HIVES RELIEF10MGTABLET / ORALRLD2007-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019835-003ZYRTEC ALLERGY5MGTABLET / ORALRLD2007-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019835-004ZYRTEC ALLERGY10MGTABLET / ORALRLD, RS2007-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019835-005ZYRTEC HIVES RELIEF5MGTABLET / ORALRLD2007-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019835-006ZYRTEC HIVES RELIEF10MGTABLET / ORALRLD2007-11-165bbf6a4d5a75…

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 LLC31136e3a-94fa-0860-e063-6394a90a008d2025-06-16WarningsExact identifier
ndc (package): 50580-116-30
ndc (product): 50580-116
ndc11 (package): 50580011630
spl id: 37b38291-50c9-00c9-e063-6394a90a83ef
spl set id: 31136e3a-94fa-0860-e063-6394a90a008d

Reported adverse events (FAERS/openFDA)#

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