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Name:Berkley And Jensen Cetirizine Hydrochloride
Manufacturer:Bjwc
Category:Over-the-counter (OTC) Marketed Drugs


BJWC Cetirizine Hydrochloride Tablets Drug Facts

BERKLEY AND JENSEN CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet 
BJWC

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BJWC Cetirizine Hydrochloride Tablets Drug Facts

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

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.

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

Other information

  • do not use if printed foil under cap is broken or missing
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, FD&C blue no. 1, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

Questions or comments?

1-800-934-1204

Principal Display Panel

Compare to the active ingredient in Zyrtec®

Cetirizine Hydrochloride Tablets, 10 mg

Antihistamine

All Day Allergy

Indoor & Outdoor Allergies

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

24 Hour

All Day Allergy

Actual Size

Cetirizine Hydrochloride Tablets Stretch Pack

Cetirizine Hydrochloride Tablets Stretch Pack


BERKLEY AND JENSEN CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-458
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 4H2
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68391-458-87 1 BOTTLE ( BOTTLE) in 1 PACKAGE contains a BOTTLE
1 300 TABLET ( TABLET) in 1 BOTTLE This package is contained within the PACKAGE (68391-458-87)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078336 04/27/2009

Labeler - BJWC (159082692)

Revised: 05/2009 BJWC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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