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



Cetirizine HCl Capsules 10 mg (Allergy)

Drug Facts


Active Ingredient (In Each Capsule)



Cetirizine HCI 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.


Otc - Ask Doctor



Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.


Otc - Ask Doctor/Pharmacist



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 capsule once daily;
do not take more than one 10 mg
capsule 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 at 20°-25°C (68°-77°F)
  • avoid high humidity and excessive heat above 40°C (104°F)
  • protect from light
  • do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.


Inactive Ingredients



black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution


Questions Or Comments?



call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)


DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
Walgreens.com ©2019 Walgreen Co.


Package Label-Principal Display Panel - 10 Mg (12'S Capsule Container Label)



ALLERGY    NDC 0363-0068-53
Original Prescription Strength

Cetirizine HCl Capsules

10 mg
INDOOR + OUTDOOR 
ALLERGIES                                    
CZ10

Antihistamine                              (Actual Size)

READ AND KEEP THE OUTER PACKAGE FOR
COMPLETE WARNINGS AND INFORMATION

12 LIQUID GELS*

* LIQUID-FILLED CAPSULES
AUROHEALTH


Package Label-Principal Display Panel -10 Mg (12'S Capsule Container Carton Label)



Original Prescription Strength
 ALLERGY       NDC 0363-0068-12

Cetirizine HCl Capsules
10 mg
Antihistamine
INDOOR +OUTDOOR               CZ10
ALLERGIES                             (Actual Size)


24 HOUR

RELIEF OF

* Please review the disclaimer below.