FDA.reportPublic FDA data

Cetirizine Hydrochloride Capsules - Kroger

Manufacturer
Praxis, LLC
Effective date
2023-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:37:07

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

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 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

FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

call toll free 1-800-632-6900

SPL UNCLASSIFIED SECTION

Zyrtec® is a registered trademark of Johnson & Johnson

Corporation, New Brunswick, New Jersey 08933. Johnson & Johnson

Corporation is not affiliated with The Kroger Co. or this product.

DISTRIBUTED BY

THE KROGER CO.,

CINCINNATI,

OHIO 45202

QUALITY GUARANTEE

800-632-6900

www.kroger.com

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP THIS CARD FOR COMPLETE

WARNINGS AND PRODUCT INFORMATION

L0000553

R0122

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient
of ZYRTEC® LIQUID GELS *See back panel

Kroger

All Day
Allergy

Cetirizine Hydrochloride
Capsules, 10 mg

Antihistamine

INDOOR & OUTDOOR

ALLERGIES

24 HOUR RELIEF OF:

Sneezing, Runny Nose; Itchy, Watery Eyes

& Itchy Throat or Nose

24

HOUR

SYMPTOM

RELIEF

actual size

40 SOFTGELS†

†liquid-filled capsules

40's card40's card

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59368-39159368-391-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
MANNITOL3OWL53L36AIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
CETIRIZINE HYDROCHLORIDE64O047KTOAACTIB

Source Document#

Source XML

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
36e8faa4-278b-bcbe-e063-6394a90ad93136e9041d-9bc0-c4ee-e063-6394a90a11962023-01-01WarningsExact identifier
spl id: 36e8faa4-278b-bcbe-e063-6394a90ad931
spl set id: 36e9041d-9bc0-c4ee-e063-6394a90a1196

Reported adverse events (FAERS/openFDA)#

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