Cetirizine Hydrochloride

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

For 5 mg:

Cetirizine hydrochloride 5 mg

For 10 mg:

Cetirizine hydrochloride 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

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For 5 mg:

adults and children 6 years and over	1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over	1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

For 10 mg:

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

• store between 20° to 25°C (68° to 77°F)

Spl Unclassified Section

Inactive ingredients corn starch, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, titanium dioxide

Questions or comments?

Spl Unclassified Section

call toll free 1-800-818-4555 weekdays

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 5 mg 30 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC  57664-540-83

Cetirizine Hydrochloride Tablets,  5 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 5 mg 30 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC  57664-540-83

Cetirizine Hydrochloride Tablets, 5 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 10 mg 30 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC  57664-541-83

Cetirizine Hydrochloride Tablets, 10 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 10 mg 30 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC  57664-541-83

Cetirizine Hydrochloride Tablets, 10 mg

Antihistamine

ALLERGY

30 Tablets

Caraco Pharmaceutical Laboratories, Ltd.

DailyMed Billing Units#

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
• CELLULOSE, MICROCRYSTALLINE
• STARCH, CORN
• POVIDONE
• MAGNESIUM STEARATE
• HYPROMELLOSE
• POLYETHYLENE GLYCOL
• POLYSORBATE 80
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 264 matching rows.

Orange Book application contexts#

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Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

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.

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.

Reported adverse events (FAERS/openFDA)#

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