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

Menu
Search

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Sun Pharmaceutical Industries Limited


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients



Purpose



Cetirizine Hydrochloride and Pseudoephedrine 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
    • nasal congestion
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily restores freer breathing through the nose

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.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (cer tain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • diabetes
  • glaucoma
  • high blood pressure
  • trouble urinating due to an enlarged
  • prostate gland
  • 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

  • do not use more than directed 
  • 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.
  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever

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

  • do not break or chew tablet; swallow tablet whole
adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.
adults 65 years and over ask a doctor
children under 12 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

Cetirizine Hydrochloride and Pseudoephedrine 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?


Call toll free 1-800-818-4555 weekdays

Principal Display Panel


NDC 62756-915-83
Original Prescription Strength

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP
5 mg/120 mg
Antihistamine/Nasal Decongestant
Indoor & Outdoor Allergies
ALLERGY & CONGESTION
30 EXTENDED-RELEASE TABLETS
SUN PHARMA
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62756-915
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CETIRIZINE HYDROCHLORIDE CETIRIZINE 5 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 120 mg

Inactive Ingredients

Ingredient Name Strength
hydroxypropyl cellulose
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
STEARIC ACID
titanium dioxide
AMMONIA
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
propylene glycol
SHELLAC

Product Characteristics

Color Size Imprint Code Shape
WHITE 9 mm 915 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62756-915-83 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090922 2012-09-29


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.