Cetirizine Hydrochloride Tablets

Manufacturer
H E B
Effective date
2025-05-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:16

Label at a glance#

ProductAll Day Allergy
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 white ink, (isopropyl alcohol, propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide) purified water, sodium hydroxide, sorbitan, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Zyrtec® active ingredient*

Allergy Relief

Cetirizine HCl Capsules, 10 mg /

Antihistamine

Indoor & Outdoor Allergies

Relief of:

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

LIQUID GELS†

(†LIQUID FILLED CAPSULES

10 mg each

*This product is not manufactured or distributed by Kenvue Brands LLC., 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.

MADE WITH PRIDE AND CARE FOR H-E-B®

SAN ANTONIO, TX 78204

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

H-E-B Allergy Relief
H-E-B Allergy Relief

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-216ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE, LIQUID FILLED [H E B]2Unmatched20250503_f690b638-8106-4050-a062-25b7724feea9.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
37808-21637808-216-25, 37808-216-40

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

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
fb1f80c7-7f1a-43b1-8d42-45a9329882edf690b638-8106-4050-a062-25b7724feea92025-10-10WarningsExact identifier
spl set id: f690b638-8106-4050-a062-25b7724feea9

Reported adverse events (FAERS/openFDA)#

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