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:
Cetirizine hydrochloride 5 mg
 
For 10 mg:
Cetirizine hydrochloride 10 mg

Purpose


Cetirizine Hydrochloride Uses


relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings


Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

  • trouble swallowing
  • dizziness or loss of consciousness
  • swelling of tongue
  • swelling in or around mouth
  • trouble speaking
  • drooling
  • wheezing or problems breathing
immediately

Not a Substitute for Epinephrine.

Do not use


  • to prevent hives from any known cause such as:
    • foods
    • insect stings
    • medicines
    • latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
  • 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.
  • hives that are an unusual color, look bruised or blistered
  • hives that do not itch

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


  • an allergic reaction to this product occurs. Seek medical help right away.
  • symptoms do not improve after 3 days of treatment
  • the hives have lasted more than 6 weeks

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 Hives Relief:
Original Prescription Strength
NDC 47335-343-16
Children's
Cetirizine Hydrochloride Chewable Tablets
5 mg
HIVES Relief
Antihistamine
24 hour Relief of ITCHING Due to Hives
Tutti-frutti Flavor
6 yrs. & older
100 CHEWABLE TABLETS
SUN PHARMACEUTICAL INDUSTRIES LTD.
Cetirizine Hydrochloride
Cetirizine Hydrochloride
Cetirizine Hydrochloride
Cetirizine Hydrochloride
Cetirizine Hydrochloride
For 10 mg Hives Relief:
Original Prescription Strength
NDC 47335-344-16
Children's
Cetirizine Hydrochloride Chewable Tablets
10 mg
HIVES Relief
Antihistamine
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

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:47335-343-15 30 in 1 BOTTLE
2 NDC:47335-343-16 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090142 2011-09-26


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:47335-344-15 30 in 1 BOTTLE
2 NDC:47335-344-16 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090142 2011-09-26


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