Cetirizine Hydrochloride

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

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

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
• 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 right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet 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

SPL UNCLASSIFIED SECTION

• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/stand-alone labels only)
• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
• store between 20° to 25° C (68° to 77° F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

call 1-800-406-7984

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE
INGREDIENT IN ZYRTEC^®*

Original Prescription Strength

Premier
Value^®

24 Hour Allergy Relief

Cetirizine HCl Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

Relief of:

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

90
Tablets
10 mg Each

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

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DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

• Cetirizine Hydrochloride
• CETIRIZINE
• STARCH, CORN
• HYPROMELLOSE, UNSPECIFIED
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• TALC
• TITANIUM DIOXIDE
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POVIDONE, UNSPECIFIED

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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Inactive ingredient links page 1 of 1 · 35 matching rows.

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Current product rows page 1 of 1 · 4 matching rows.

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 · 176 observed states.

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Reported adverse events (FAERS/openFDA)#

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