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

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Cetirizine Hydrochloride

Amneal Pharmaceuticals
Amneal Pharmaceuticals

CETIRIZINE HYDROCHLORIDE TABLETS




FULL PRESCRIBING INFORMATION

Drug Facts

(in each tablet)

Cetirizine HCl 5 mg

Antihistamine

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 drink

● 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 breast-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.

Adults andchildren 6years andover 1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
Adults 65years andover 1 tablet once a day; do not take more than 1 tablet in 24 hours.
Childrenunder 6 yearsof age ask a doctor
Consumerswith liver orkidneydisease ask a doctor

Other information

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

Inactive ingredients

lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, povidone, starch, talc and titanium dioxide.

Questions or Comments?

Call 1-877-835-5472

Monday through Friday 9AM-5PM EST

Distributed by:  Amneal Pharmaceuticals

Glasgow, KY 42141

Rev. 01-2009

Cetirizine HydrochlorideCetirizine HydrochlorideCetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65162-045
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 5 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
polyethylene glycol
povidone
STARCH, CORN
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 6 mm IP;45 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 NDC:65162-045-50 500 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078780 2010-01-21


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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