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  5. Label Information: Cetirizine Hcl And Pseudoephedrine Hcl ER

FDA Label for Cetirizine Hcl And Pseudoephedrine Hcl ER

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (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. STORAGE AND HANDLING
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. OTHER
    17. HOW SUPPLIED
    18. 5 MG/120 MG LABEL

Cetirizine Hcl And Pseudoephedrine Hcl ER Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. 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 Ingredient (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
    • itchy, watery eyes
    • nasal congestion
    • sneezing
    • itching of the nose or throat
    • 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.



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 doctor
    children under 12 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

Other Information



  • Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
  • DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN (for blister package only).

Storage And Handling



Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).


Inactive Ingredients



Colloidal silicon dioxide, croscarmellose sodium, D & C yellow aluminum lake, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, and titanium dioxide.


Questions Or Comments?



1-800-525-8747


Other



Sandoz Inc.

Princeton, NJ 08540

05-2010M



Relabeling of Additional Barcode by:
Physicians Total Care, Inc.
Tulsa, OK     74146


How Supplied



HOW SUPPLIED:


30 Tablets, Bottles              NDC 54868-5884-1

60 Tablets, Bottles              NDC 54868-5884-0

24 Tablets, Blister Pack      NDC 54868-5884-2


5 Mg/120 Mg Label



Cetirizine HCl and

Pseudoephedrine HCl

Extended Release Tablets

5 mg/120 mg

antihistamine/

nasal decongestant

Indoor & Outdoor Allergies

ALLERGY & CONGESTION

12 hour Relief of

Runny Nose Itchy, Watery Eyes Sinus Pressure

Sneezing Itchy Throat or Nose Nasal Congestion


* Please review the disclaimer below.