FDA Label for Cetirizine Hydrochloride (allergy)

View Indications, Usage & Precautions

Cetirizine Hydrochloride (allergy) Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Co.. 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.

Other




Drug Facts


Active Ingredient (In Each Tablet)




Cetirizine hydrochloride 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

Warnings



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



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

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide


Questions?



call 1-855-274-4122

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

MADE IN INDIA

Code: TS/DRUGS/19/1993


Package Label-Principal Display Panel - 10 Mg (30 Tablets Container Label)



ORIGINAL
PRESCRIPTION STRENGTH
Walgreens
NDC 0363-9602-09
 Allergy Relief
24 HOUR ALLERGY
CETIRIZINE HYDROCHLORIDE
TABLETS
USP 10 mg / ANTIHISTAMINE
30 TABLETS
10 mg EACH




Package Label-Principal Display Panel - 10 Mg (30 Tablets Container Carton Label)



ORIGINAL PRESCRIPTION STRENGTH
Walgreens
Compare to the active ingredient
in Zyrtec®††

NDC 0363-9602-09
Allergy Relief
24 HOUR
ALLERGY
24
HOUR
CETIRIZINE HYDROCHLORIDE TABLETS USP 10 mg / ANTIHISTAMINE
24 Hour   Tablets  Indoor & Outdoor Allergies

•    24-hour relief of sneezing; runny nose; itchy,
      watery eyes & itchy throat or nose

Actual Size
30
TABLETS            10 mg EACH



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