Cetirizine Hydrochloride Tablets

Label at a glance#

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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 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

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, sorbitan, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free:

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Zyrtec®

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

LIQUID GELS**

(**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:

ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

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Products#

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

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

• All Day Allergy
• Cetirizine HCl
• CETIRIZINE HYDROCHLORIDE
• CETIRIZINE
• GELATIN
• ISOPROPYL ALCOHOL
• POLYETHYLENE GLYCOL 400
• PROPYLENE GLYCOL
• SODIUM HYDROXIDE
• SORBITAN
• SORBITOL
• SHELLAC
• SODIUM LAURYLSULFONATE
• TITANIUM DIOXIDE
• WATER
• MEDIUM-CHAIN TRIGLYCERIDES

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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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 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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