1. Home
  2. Labeler Index
  3. Physicians Total Care, Inc.
  4. 54868-5855
  5. Label Information: Cetirizine Hydrochloride

FDA Label for Cetirizine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    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. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride 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



Cetirizine Hydrochloride 5 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.


Directions



adults and children
6 years and over		1 to 2 tablets once daily depending upon severity of symptoms; do not take more than
2 tablets in 24 hours.
adults 65 years
and over		1 tablet once a day; do not take more than
1 tablet in 24 hours
children under
6 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)

Inactive Ingredients



anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin


Questions?



call 1-877-446-3679

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505


Package Label.Principal Display Panel



 PRINCIPAL DISPLAY PANEL - 5 mg Hives Relief

NDC 54868-5855-0

Cetirizine Hydrochloride
Tablets 5 mg
antihistamine

24
HOUR

Relief of
ITCHING
Due to Hives

Tamper Evident: do not use if foil seal under cap
is missing, open or broken

Cetirizine Hydrochloride Tablets 5 mg package label - 5855

Cetirizine Hydrochloride Tablets 5 mg package label - 5855


* Please review the disclaimer below.