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  5. Label Information: Cetirizine Hydrochloride

FDA Label for Cetirizine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 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. PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Publix Super Markets 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 Tablet)



Cetirizine HCl, USP 10 mg


Purpose



Antihistamine


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

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.


Ask A Doctor Before Use If You Have



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



  • 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.


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



adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Other Information



  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • store between 20° to 25° C (68° to 77° F)

Inactive Ingredients



Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide


Principal Display Panel



Publix

INDOOR & OUTDOOR

allergy relief

CETIRIZINE HYDROCHLORIDE TABLETS, 10 mg

ANTIHISTAMINE

24 hour relief of:

  • sneezing
  • itchy, watery eyes
  • runny nose
  • itchy throat or nose

    • Original Prescription Strength

    60 TABLETS 10 mg EACH

    *Compare to Active Ingredient in Zyrtec®

    DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.

    5087913/R0711


* Please review the disclaimer below.