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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
    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?
    15. PRINCIPAL DISPLAY PANEL - SHOWBOX
    16. PRINCIPAL DISPLAY PANEL - BLISTER PACK

Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Sun Pharmaceutical Industries, 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 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

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.

spl-cetirizine-pseudoephedrine-blister - spl cetirizine pseudoephedrine blister

spl-cetirizine-pseudoephedrine-blister - spl cetirizine pseudoephedrine blister


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