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Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Medically reviewed on May 14, 2018

Dosage form: tablet, film coated, extended release
Ingredients: CETIRIZINE HYDROCHLORIDE 5mg, PSEUDOEPHEDRINE HYDROCHLORIDE 120mg
Labeler: Sun Pharmaceutical Industries Limited
NDC Code: 62756-915

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP

Active ingredients

Cetirizine HCl, USP 5 mg
Pseudoephedrine HCl, USP 120 mg

Purpose

Antihistamine
Nasal Decongestant

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 overask a doctor
children under 12 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) 
  • do not use if inner safety seal is open or torn
  • see top layer for lot number and expiration date

Inactive ingredients

hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide
Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze

Questions?

Call toll free 1-800-818-4555 weekdays

Principal Display Panel - Showbox

NDC 62756-915-62
Original Prescription Strength
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets, USP
5 mg/120 mg
Antihistamine/Nasal Decongestant
Indoor & Outdoor Allergies
ALLERGY & CONGESTION
SUN PHARMA
DO NOT USE IF INDIVIDUAL BLISTER UNIT IS OPEN OR TORN
12 Tablets (2 blister cards of 6 tablets each)

Principal Display Panel - Blister pack


Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablet, USP
5 mg/120 mg
Mfg. by: Sun Pharmaceutical Ind. Ltd. India.

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 
cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62756-915
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE5 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE (TYPE H) 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
TITANIUM DIOXIDE 
AMMONIA 
FERROSOFERRIC OXIDE 
ISOPROPYL ALCOHOL 
BUTYL ALCOHOL 
PROPYLENE GLYCOL 
SHELLAC 
Product Characteristics
ColorWHITEScoreno score
ShapeROUND (circular) Size9mm
FlavorImprint Code915
Contains    
Packaging
#Item CodePackage Description
1NDC:62756-915-8330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
2NDC:62756-915-631 BLISTER PACK in 1 CARTON
26 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
3NDC:62756-915-622 BLISTER PACK in 1 CARTON
36 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
4NDC:62756-915-734 BLISTER PACK in 1 CARTON
46 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09092209/29/2012
Labeler - Sun Pharmaceutical Industries Limited (650172430)
Establishment
NameAddressID/FEIOperations
Sun Pharmaceutical Industries Limited650445203ANALYSIS(62756-915), MANUFACTURE(62756-915)

 
Sun Pharmaceutical Industries Limited

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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