Cetirizine Hydrochloride Tablets

Manufacturer
WALMART INC. (see also Equate)
Effective date
2025-04-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:59:56

Label at a glance#

ProductAllergy Relief
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure16 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

Adults and children 6 years and over One 10 mg capsule once daily; do not take more than one 10 mg capsule 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 at 20º -25ºC (68º - 77ºF) avoid high humidity and excessive heat above 40ºC (104ºF) protect from light

Label contents#

Full prescribing information#

Active Ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl USP,10 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

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years and overOne 10 mg capsule once daily; do not take more than one 10 mg capsule 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 Information

STORAGE AND HANDLING SECTION

  • store at 20º -25ºC (68º - 77ºF)
  • avoid high humidity and excessive heat above 40ºC (104ºF)
  • protect from light

Inactive Ingredients

INACTIVE INGREDIENT SECTION

gelatin, medium chain triglyceride, polyethylene glycol 400, printing ink white (isopropyl alcohol, propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide) purified water, sodium hydroxide, sorbitol-sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Zyrtec® active ingredient*

Allergy Relief

Cetirizine HCl Capsules, 10 mg 

Antihistamine

Indoor & Outdoor Allergies

24-hour relief of

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

SOFTGELS**

**Liquid filled capsules

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Zyrtec®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

Walmart Inc.,

Bentonville, AR 72716

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUATE Allergy Relief
EQUATE Allergy Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN4
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD4
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79903-344-25Allergy Relief25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED254
79903-344-25Allergy Relief1 in 1 BOXCAPSULE, LIQUID FILLED14
79903-344-50Allergy Relief25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED254
79903-344-50Allergy Relief1 in 1 BOXCAPSULE, LIQUID FILLED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-344ALLERGY RELIEF (CETIRIZINE HCL) CAPSULE, LIQUID FILLED [WALMART INC. (SEE ALSO EQUATE)]4Current NDC, 4 package rows20250430_41bc1339-7137-4472-b47b-a7a36e24a9bb.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79903-34479903-344-50, 79903-344-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205291-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2017-07-21

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21c2088c7a36db…
2026-09-14 22:38:342026-08A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2184e616aacf4f…
2026-08-18 06:07:402026-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213f01610625f2…
2019-09-15 20:21 UTC2019-09A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205291-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2017-07-213a93d1ddd44b…

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 HCLWALMART INC. (see also Equate)41bc1339-7137-4472-b47b-a7a36e24a9bb2025-04-29WarningsExact identifier
ndc (package): 79903-344-50
ndc (package): 79903-344-25
ndc (product): 79903-344
ndc11 (package): 79903034425
ndc11 (package): 79903034450
spl id: cba66cc9-b3ad-449c-af8b-5f5214c5d452
spl set id: 41bc1339-7137-4472-b47b-a7a36e24a9bb

Reported adverse events (FAERS/openFDA)#

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