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

Cetirizine Hydrochloride

Dr.Reddy's Laboratories Limited

  • 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
Cetirizine Hydrochloride Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Cetirizine HCl, 10mg

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 antihistaminecontaining 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

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

Inactive ingredients

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

Questions?

call 1-888-375-3784.

PRINCIPAL DISPLAY PANEL - Container Labeling

10 mg Container LabelingPRINCIPAL DISPLAY PANEL - Container Labeling

PRINCIPAL DISPLAY PANEL - Containers

10 mg Containers:PRINCIPAL DISPLAY PANEL - Containers

    

    

Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55111-351
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 monohydrate
MAGNESIUM STEARATE
polyethylene glycol 400
povidone
STARCH, CORN
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 6 mm RDY;351 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE
2 45 in 1 BOTTLE
3 60 in 1 BOTTLE
4 90 in 1 BOTTLE
5 120 in 1 BOTTLE
6 175 in 1 BOTTLE
7 75 in 1 BOTTLE
8 7 in 1 BLISTER PACK
9 NDC:55111-351-74 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078343 2008-01-15


Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55111-699
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 monohydrate
MAGNESIUM STEARATE
polyethylene glycol 400
povidone
STARCH, CORN
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 7 mm C OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 90 in 1 BOTTLE
2 45 in 1 BOTTLE
3 30 in 1 BOTTLE
4 75 in 1 BOTTLE
5 120 in 1 BOTTLE
6 175 in 1 BOTTLE
7 175 in 1 BOTTLE
8 60 in 1 BOTTLE
9 365 in 1 BOTTLE
10 7 in 1 BLISTER PACK
11 NDC:55111-699-74 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078343 2008-01-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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