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  5. Label Information: Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride

FDA Label for Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH EXTENDED RELEASE TABLET)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING:
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Padagis Israel Pharmaceuticals Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Extended Release Tablet)



Cetirizine HCl 5 mg

Pseudoephedrine HCl 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

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) (certain 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. (1-800-222-1222)


Directions



  • •do not break or chew tablet; swallow tablet whole
    • adults and children 12 years and overtake 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours.adults 65 years and overask a doctorchildren under 12 years of ageask a doctorconsumers with liver or kidney diseaseask a doctor
     
     
     
     
     
     
     
     

Other Information



  • •store between 20° to 25°C (68° to 77°F)
  • •do not use if blister unit is broken or torn
  • •see side panel for lot number and expiration date
  • •meets USP Dissolution Test 2

Inactive Ingredients



colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to Zyrtec-D®

active ingredients

Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride

Extended Release Tablets

5 mg/120 mg

Antihistamine / Nasal Decongestant

12 Hour Relief of:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat or Nose

Sinus Pressure

Nasal Congestion

Original Prescription Strength

actual size

Indoor & Outdoor Allergies

12 Extended Release Tablets

Allergy & Congestion


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