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

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Cetirizine Hydrochloride

Taro Pharmaceuticals U.S.A., Inc.

Cetirizine Hydrochloride


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Cetirizine Hydrochloride 10 mg

Purpose

Antihistamine

Cetirizine Hydrochloride 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

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
  • 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 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. (1-800-222-1222)

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

Cetirizine Hydrochloride Other information

  • do not use if carton is opened, or if imprinted inner safety seal on bottle is broken or missing
  • store between 20° to 25°C (68° to 77°F)
  • for lot number and expiry date see carton or bottle label.

Inactive ingredients

corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.

Questions?

Call 1-866-923-4914

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

Compare to the
active ingredient
in Zyrtec®*

NDC 51672-2097-1

Cetirizine
Hydrochloride
Tablets 10 mg
Antihistamine

ALLERGY

Indoor & Outdoor Allergies

24
Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

100
Tablets
10 mg each

Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51672-2097
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
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POVIDONES
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm CT;10 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:51672-2097-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078072 2009-07-22


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Be sure to consult your doctor before taking any medication!
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