FDA Label for Cetirizine Hydrochloride

View Indications, Usage & Precautions

Cetirizine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Sportpharm Llc. 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.

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 Useif you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.


When Using This Product



  • drowsines may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinary.

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 overAsk a doctor
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk a doctor


Other Information:



store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].


Inactive Ingredients



Hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.


Questions?



Call 1-844-874-7464


Other



Distributed by:

Sportpharm LLC

379 Van Ness Ave 1401,

Torrance, CA 90501

Relabeled and Repackaged by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501


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