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

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Cetirizine Hydrochloride

KAISER FOUNDATION HOSPITALS
Unique Pharmaceutical Laboratories

Cetirizine Hydrochloride Tablets 10 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

NDC 0179-8301-01
Original Prescription Strength

Cetirizine Hydrochloride

Cetirizine Hydrochloride
10 mg Tablets

ANTIHISTAMINE / ALLERGY

For indoor & outdoor allergies

Purpose

Uses

24 Hour Relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • Itchy throat or Nose

*Compare to Zyrtec®

100 Tablets

Do not use if imprinted foil inner seal on bottle is broken or missing

Drug Facts

Active Ingredients (in each tablet)
Cetirizine HCl 10 mg
Purpose
Antihistamine

Purpose

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of 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

  • drowsines 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

Adult 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

Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide

Questions?

Call 1-866-562-4597

Zyrtec® is registered trademark of McNeil Consumer & Specialty Pharmaceuticals. This product is not manufactured, distributed or marketed by McNeil Consumer & Specialty Pharmaceuticals

Manufactured for Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Worli, Mumbai-400 030, India.
Distributed by Kaiser Foundation Hospitals, Livermore, CA, 94551-9756.

PRINCIPAL DISPLAY PANEL - 10 mg Container Label Text

Original Prescription Strength NDC 0179-8301-01

Cetirizine Hydrochloride

Cetirizine Hydrochloride
10 mg Tablets

ANTIHISTAMINE I ALLERGY
For indoor and outdoor allergies

24 hour relief of:

  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy throat or nose

* Compare to Zyrtec®
100 Tablets

Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0179-8301
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
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
STARCH, CORN
POLYETHYLENE GLYCOLS
POVIDONES
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white (White) 8 mm CTN;10 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0179-8301-01 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077829 2013-12-13


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Be sure to consult your doctor before taking any medication!
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