Cetirizine description, usages, side effects, indications, overdosage, supplying and lots more!

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Cetirizine

NCS HealthCare of KY, Inc dba Vangard Labs

Cetirizine Hydrochloride Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient(s)

Cetirizine Hydrochloride 10mg 

Purpose

Artihistamine 

Use(s)

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose

• sneezing

• itchy, watery eyes

• itching of the nose or thoat 

Warnings

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

• alcohol, sedatives, and tranquilizers may increase drowsiness

• avoid alcoholic drinks

• 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 breast-feeding:

• If pregnant ask a health professional before use

• If breast-feeding: not recommended 

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 10mg tablet once daily, do not take more than one 10mg tablet in 24 hours. A 5mg 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           

Cetirizine Other information

Manufactured in India by

Sandoz Private Ltd. for

Sandoz, Inc.

Princeton, NJ 08540

Rev. 03-2008

Storage

• store between 20º to 25ºC (68º to 77ºF) 

Inactive ingredients

corn starch, hypromellose, lactose monohydrate, macrogol, magensium stearate, povidone and titanium dioxide 

Questions?

1-800-525-8747 

Principal Display Panel

Cetirizine

 

Cetirizine

Cetirizine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0615-7522(NDC:0781-1684)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 10 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
lactose monohydrate
POLYETHYLENE GLYCOLS
MAGNESIUM STEARATE
POVIDONES
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE (white to off-white) 8 mm SZ;906 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-7522-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077946 2007-12-27


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Be sure to consult your doctor before taking any medication!
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