CETIRIZINE HYDROCHLORIDE description, usages, side effects, indications, overdosage, supplying and lots more!

CETIRIZINE HYDROCHLORIDE

Northstar Rx LLC
Orchid Chemicals & Pharmaceuticals Ltd.

  • 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

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Cetirizine hydrochloride USP, 10 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 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.

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

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

corn starch, lactose monohydrate, povidone, magnesium stearate and opadry white. The components of opadry white are: hydroxypropyl methylcellulose, polyethylene glycol 400, titanium dioxide

call toll free 1-800-206-7821

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16714-271-02

Cetirizine Hydrochloride Tablets, USP 10 mg

6 Years and Older

Allergy

Antihistamine

24 Hour Relief of

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

NORTHSTAR

100 Tablets

 PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:16714-271
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
lactose monohydrate
POVIDONE K29/32
MAGNESIUM STEARATE

Product Characteristics

Color Size Imprint Code Shape
white (white to off-white) 9 mm S;521 capsule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16714-271-02 100 in 1 BOTTLE, PLASTIC
2 NDC:16714-271-03 300 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078862 2009-10-19


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Be sure to consult your doctor before taking any medication!
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