FDA Label for Cetirizine Hydrochloride

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH TABLET)
PURPOSE
USES
OTC - DO NOT USE
OTC - ASK DOCTOR
OTC - ASK DOCTOR/PHARMACIST
OTC - WHEN USING
OTC - STOP USE
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Medvantx, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)

Cetirizine hydrochloride USP, 10 mg

Purpose

Antihistamine

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

Otc - Do Not Use

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

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

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Otc - When Using

When using this product

•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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding:

if breast-feeding: not recommended

if pregnant: ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Directions

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

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

Inactive Ingredients

corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white. The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide

Questions Or Comments?

call toll free 1-800-206-7821

Package Label.Principal Display Panel

NDC 16714-271-02

Cetirizine Hydrochloride Tablets, USP 10 mg

6 Years and Older

Allergy