Cetirizine HCl Capsules, 10 mg dye free-Meijer

Manufacturer
Meijer Distribution Inc | Bionpharma Inc. | Patheon Softgels Inc.
Effective date
2026-04-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:55:34

Label at a glance#

ProductCetirizine HCl
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure10 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 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

Warnings

WARNINGS SECTION

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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

*"This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademark Zyrtec®

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

KEEP THIS CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DIST. BY:
MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

R0126 L0001220

Principal Display Panel-25s count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 79481-0671-2

Compare tp the active

ingredient in zyrtec ®ⱡ

meijer

24 Hour

Allergy

Cetitizine HCl Capsules,

10 mg| Antihistamine

24

HOUR

RELIEF OF:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

25

SOFTGELS*

*Liquid-filled capsules

image001image001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN2
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD2
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0671-2Cetirizine HCl25 in 1 BOTTLE, PLASTICCAPSULE252
79481-0671-2Cetirizine HCl1 in 1 CARTONCAPSULE12

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
79481-067179481-0671-2

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
N022429-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGCAPSULE / ORALRLD2009-07-23
N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORALRLD, RS2009-07-23
N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MGCAPSULE / ORALRLD2009-07-23
N022429-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORALRLD, RS2009-07-23

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 22:38:342026-08N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-2384e616aacf4f…
2026-09-14 22:38:342026-08N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-2384e616aacf4f…
2026-09-14 22:38:342026-08N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-2384e616aacf4f…
2026-09-14 22:38:342026-08N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-2384e616aacf4f…
2026-08-18 06:07:402026-07N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-23caaa826d4ba7…
2026-08-18 06:07:402026-07N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022429-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGCAPSULE / ORALRLD2009-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022429-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORALRLD, RS2009-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022429-003CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGCAPSULE / ORALRLD2009-07-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022429-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORALRLD, RS2009-07-235bbf6a4d5a75…

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
Cetirizine HClCETIRIZINE HCLMeijer Distribution Inc3143de16-2006-ec2e-e063-6294a90a1f672026-04-20WarningsExact identifier
ndc (package): 79481-0671-2
ndc (product): 79481-0671
ndc11 (package): 79481067102
spl id: 4fe7adc4-4ee8-8294-e063-6394a90a3e17
spl set id: 3143de16-2006-ec2e-e063-6294a90a1f67

Reported adverse events (FAERS/openFDA)#

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