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 Quagen Pharmaceuticals 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.

Active Ingredient (In Each 5 Ml)



Cetirizine HCl 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

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

If Pregnant Or Breast-Feeding:



  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.

Directions



  • use only with enclosed dosing cup
  • find right dose on chart below
  • mL = milliliter
  • adults and children 6 years and over5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. 
    adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours.
    children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
    children under 2 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)
  • Protect from light
  • do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing
  • see bottom panel for lot number and expiration date

Inactive Ingredients



Bubble Gum Syrup: anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Grape Syrup: anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose


Questions?



Call 1-888-344-9603 (toll-free)


Principal Display Panel - Bubble Gum Flavor - Container Label




Principal Display Panel - Bubble Gum Flavor - Carton Label




Principal Display Panel - Grape Flavor - Container Label




Principal Display Panel - Grape Flavor-Carton Label




* Please review the disclaimer below.