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  5. Label Information: Cetirizine Hydrochloride

FDA Label for Cetirizine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - STOP USE
    10. WARNINGS
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 10 MG

Cetirizine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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 HCl, 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

Otc - Do Not Use



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



  • 1.drowsiness may occur
  • 2.avoid alcoholic drinks
  • 3.alcohol, sedatives, and tranquilizers may increase drowsiness
  • 4.be careful when driving a motor vehicle or operating machinery

Otc - Stop Use



Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.


Warnings



If pregnant or breast-feeding:

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

Otc - Keep Out Of Reach Of Children



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

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° and 25°C (68° - 77°F)
  • •USP Dissolution Test 3

Inactive Ingredients



Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and titanium dioxide.


Questions Or Comments?



call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

Manufactured by:

Manufactured for:

Repackaged by:

Apotex Inc.

Apotex Corp.

Proficient Rx LP

Toronto, Ontario

Weston, Florida

Thousand Oaks, CA 91320

Canada M9L 1T9

33326


Principal Display Panel - 10 Mg



APOTEX CORP. NDC 63187-932-30

Cetirizine 10 mg

Cetirizine Hydrochloride Tablets

Antihistamine/Original Prescription Strength 

Indoor & Outdoor Allergies

24 hour

Relief of

* Please review the disclaimer below.