FDA Label for Cetirizine Hydrochloride

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT ( IN EACH TABLET)
PURPOSE
USES
DO NOT USE
ASK A DOCTOR BEFORE USE IF YOU HAVE
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAT-FEEDING
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
INACTIVE INGREDIENTS
QUESTIONS?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Ipca Laboratories Limited. 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.

Other

Drug Facts:

Other information

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

Manufactured for:

Ohm Laboratories Inc.

14 Terminal Road

New Brunswick, NJ 08901

Manufactured by:

Ipca Laboratories Limited

1, Pharma Zone, SEZ Indore,

Pithampur 454775, (M.P.), India

Active Ingredient ( In Each Tablet)

Cetirizine HCl 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

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.

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

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

Stop Use And Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breat-Feeding

if breast-feeding: not recommended
if pregnant: ask a health professional before use.

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 yearsand 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

Inactive Ingredients

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

Questions?

call 1-800-406-7984

Package Label.Principal Display Panel

Ohm Laboratories Inc.\Ranbaxy Group Company

NDC: 57451-5067-1

Cetirizine Hydrochloride Tablets 10 mg

1x 10000 Tablets

Each tablet contains:

Cetirizine hydrochloride 10 mg

Store between 20° to 25°C (68° to 77°F)

Code : MP/DRUGS/25/1/2008

Batch No. :

Mfg. Dt. :

Exp. Dt. :