692R Walgreens 0363-1794 Cetirizine HCl Tablets USP, 10 mg

Manufacturer
WALGREENS | TIME CAP LABORATORIES, INC. | Marksans Pharma Ltd
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:36

Label at a glance#

ProductAllergy Relief
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Cetirizine HCl 10 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not useif 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 haveliver 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 aretaking 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 ifan 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).

DOSAGE & ADMINISTRATION SECTION

Directions

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 over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments?Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

692R_Walgreens_Cetirizine_5s_ifc692R_Walgreens_Cetirizine_5s_ifc692R_Walgreens_Cetirizine_14s_ifc692R_Walgreens_Cetirizine_14s_ifc

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
0363-1794-38Allergy Relief1 in 1 CARTONTABLET12
0363-1794-38Allergy Relief5 in 1 BLISTER PACKTABLET52
0363-1794-46Allergy Relief1 in 1 CARTONTABLET12
0363-1794-46Allergy Relief14 in 1 BLISTER PACKTABLET142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1794ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [WALGREENS]2Current NDC, 4 package rows20231025_f3c66f47-016a-799a-e053-2995a90ad424.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-17940363-1794-38, 0363-1794-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
A078933-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-06-15
A078933-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-06-15
A078933-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2010-06-15
A078933-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2010-06-15

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 22:38:342026-08A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-1584e616aacf4f…
2026-09-14 22:38:342026-08A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-1584e616aacf4f…
2026-09-14 22:38:342026-08A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-1584e616aacf4f…
2026-09-14 22:38:342026-08A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-1584e616aacf4f…
2026-08-18 06:07:402026-07A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2010-06-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078933-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2010-06-155bbf6a4d5a75…

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
Allergy ReliefCETIRIZINE HYDROCHLORIDEWALGREENSf3c66f47-016a-799a-e053-2995a90ad4242023-10-21WarningsExact identifier
ndc (package): 0363-1794-46
ndc (package): 0363-1794-38
ndc (product): 0363-1794
ndc11 (package): 00363179438
ndc11 (package): 00363179446
spl id: 08332210-6c16-be1e-e063-6394a90a0bbe
spl set id: f3c66f47-016a-799a-e053-2995a90ad424

Reported adverse events (FAERS/openFDA)#

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