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

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Cetirizine Hydrochloride

Chain Drug Consortium, LLC
Sun Pharmaceutical Industries Limited

Cetirizine Hydrochloride Chewable Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each chewable tablet)



Cetirizine hydrochloride, USP 10 mg

Purpose


Antihistamine

Cetirizine Hydrochloride 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

  • may be taken with or without water

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


acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

Questions?


Call toll free 1-800-818-4555 weekdays

Principal Display Panel



NDC 68016-353-30
Original Prescription Strength
Children's
Cetirizine Hydrochloride
CHEWABLE TABLETS
10 mg
ALLERGY
Antihistamine
Indoor & Outdoor Allergies
Tutti-frutti Flavor
6 yrs & older
30 CHEWABLE TABLETS


Cetirizine Hydrochloride

Cetirizine Hydrochloride

Cetirizine Hydrochloride TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-353
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:68016-353-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090142 2013-09-10


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