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

Berkley and Jensen Cetirizine Hydrochloride

BJWC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
BJWC Cetirizine Hydrochloride Tablets, 10 mg Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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. (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
  • 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 aluminum lake, 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 Symptom Relief

Original Prescription Strength

Actual Size

Principal Display Panel
Cetirizine Hydrochloride Tablets, 10 mg Package Image 1 Cetirizine Hydrochloride Tablets, 10 mg Package Image 2

Berkley and Jensen Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET

Product Information

Product Type Human otc drug label 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 10 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
povidone
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
WHITE 10 mm 4H2 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 300 in 1 BOTTLE
2 365 in 1 BOTTLE
3 NDC:68391-458-88 1 in 1 PACKAGE

Marketing Information

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


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Be sure to consult your doctor before taking any medication!
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