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

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Cetirizine Hydrochloride

Sun Pharma Global FZE

Cetirizine Hydrochloride Chewable Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each chewable tablet)


For 5 mg:


For 10 mg:

Purpose


Cetirizine Hydrochloride Uses


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

Warnings

Do not use


Ask a doctor before use if you have


Ask a doctor or pharmacist before use if


you are

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 doctor if


If pregnant or breast-feeding:

 

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

Keep out of reach of children


Directions

  • may be taken with or without water

For 5 mg:



adults and children 6 years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
adults 65 years and over
 
1 tablet once a day; do not take more than 1 tablet in 24 hours
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
For 10 mg:
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

Cetirizine Hydrochloride Other information

 

  • store between 20° to 25°C (68° to 77°F)
  • do not use if inner safety seal is open or torn
  • see top layer for lot number and expiration date

Inactive ingredients


Questions?


1-800-818-4555

Principal Display Panel


For 5 mg Allergy:
Original Prescription Strength
NDC 47335-343-88

Children's
Cetirizine Hydrochloride Chewable Tablets
5 mg
ALLERGY
Antihistamine
Indoor & Outdoor Allergies
Tutti-frutti Flavor
6 yrs. & older
100 CHEWABLE TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.
Cetirizine Hydrochloride
Cetirizine Hydrochloride
Cetirizine Hydrochloride
Cetirizine Hydrochloride
For 10 mg Allergy:
Original Prescription Strength
NDC 47335-344-88
Children's
Cetirizine Hydrochloride Chewable Tablets
10 mg
ALLERGY
Antihistamine
Indoor & Outdoor Allergies
Tutti-frutti Flavor
6 yrs. & older
100 CHEWABLE TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.
Cetirizine Hydrochloride
Cetirizine Hydrochloride
Cetirizine Hydrochloride
Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:47335-343
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 5 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
SILICON DIOXIDE
SUCROSE
CROSPOVIDONE
FD&C BLUE NO. 2
FD&C RED NO. 40
GUAR GUM
magnesium oxide
MAGNESIUM STEARATE
mannitol
cellulose, microcrystalline
STARCH, CORN
talc

Product Characteristics

Color Size Imprint Code Shape
PURPLE 8 mm 343 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47335-343-83 30 in 1 BOTTLE
2 NDC:47335-343-88 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090142 2011-09-09


Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:47335-344
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
ACESULFAME POTASSIUM
SILICON DIOXIDE
SUCROSE
CROSPOVIDONE
FD&C BLUE NO. 2
FD&C RED NO. 40
GUAR GUM
magnesium oxide
MAGNESIUM STEARATE
mannitol
cellulose, microcrystalline
STARCH, CORN
talc

Product Characteristics

Color Size Imprint Code Shape
PURPLE 10 mm 344 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:47335-344-83 30 in 1 BOTTLE
2 NDC:47335-344-88 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090142 2011-09-09


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