FDA.reportPublic FDA data

Walgreens Cetirizine Tablets-Hives

Manufacturer
WALGREEN COMPANY | Bionpharma Inc. | OrBion Pharmaceuticals Private Limited
Effective date
2026-03-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:50:44

Label at a glance#

ProductHives Relief
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

store between 20° to 25°C (68° to 77°F).

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine Hydrochloride USP, 10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

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: 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 ■ trouble speaking ■ swelling in or around mouth ■ 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and overone 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 ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

store between 20° to 25°C (68° to 77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-235-2466

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

†Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.
††This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Zyrtec®.

DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com
©2025 Walgreen Co. MADE IN INDIA

L0001209 R0126

Code: TN/Drugs/TN00002222/2006
949129363

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORIGINAL PRESCRIPTION STRENGTH

Compare to the active ingredient
in Zyrtec® Hives ††

Hives Relief
CETIRIZINE HYDROCHLORIDE TABLETS USP,
10 mg / ANTIHISTAMINE

24-Hour
• 24-hour relief of itching due to hives

30 TABLETS

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN2
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2
1014678cetirizine HCl 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
0363-6340-13Hives Relief30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

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
0363-63400363-6340-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
POVIDONE K29/32390RMW2PEQIACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSE 2910 (5 MPA.S)R75537T0T4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB

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 44.

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
A078862-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-02-19
A078862-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2009-02-19
A078862-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-02-19
A078862-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2009-02-19

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-19c2088c7a36db…
2026-10-15 13:18:302026-09A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-19c2088c7a36db…
2026-10-15 13:18:302026-09A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-19c2088c7a36db…
2026-10-15 13:18:302026-09A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-19c2088c7a36db…
2026-09-14 22:38:342026-08A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-1984e616aacf4f…
2026-09-14 22:38:342026-08A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-1984e616aacf4f…
2026-09-14 22:38:342026-08A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-1984e616aacf4f…
2026-09-14 22:38:342026-08A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-1984e616aacf4f…
2026-08-18 06:07:402026-07A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-19caaa826d4ba7…
2026-08-18 06:07:402026-07A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078862-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078862-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078862-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-02-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078862-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-02-192680178bc6a6…

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
Hives ReliefCETIRIZINE TABLETSWALGREEN COMPANY4526b65c-b0e7-180c-e063-6394a90ae9162026-03-16WarningsExact identifier
ndc (package): 0363-6340-13
ndc (product): 0363-6340
ndc11 (package): 00363634013
spl id: 4d2c69cb-1f56-68a5-e063-6394a90a7074
spl set id: 4526b65c-b0e7-180c-e063-6394a90ae916

Reported adverse events (FAERS/openFDA)#

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