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  5. Label Information: Levocetirizine Dihydrochloride

FDA Label for Levocetirizine Dihydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Levocetirizine Dihydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Camber Consumer Care Inc. 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(S)



Levocetirizine dihydrochloride USP 5 mg



Purpose



Antihistamine


Use(S)



temporarily relieves these symptoms due to hay fever or other respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat



Do Not Use



• if you have kidney disease
• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine




Ask A Doctor Before Use If You Have



  • ever had trouble urinating or emptying your bladder

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



• you have trouble urinating or emptying your bladder
• 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 65 years of age and older
 		 
  • ask a doctor
    •  
 adults and children 12 to 64 years of age
 		 
  • take 1 tablet (5 mg) once daily in the evening  
  • do not take more than 1 tablet (5 mg) in 24 hours 
  • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
    •  
 children 6 to 11 years of age
 		 
  • take ½ tablet (2.5 mg) once daily in the evening 
  • do not take more than ½ tablet (2.5 mg) in 24 hours
    •  
 children under 6 years of age
 		 
  • do not use
    •  
 consumers with kidney disease
 		 
  • do not use
    •  

  



Other Information



• store between 20° and 25°C (68° and 77°F)
• safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
• safety sealed: do not use if carton was opened or if individual blister unit is open or torn




Inactive Ingredients




colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.


Questions Or Comments?



call 1-888-588-1418.

 


Distributed by:
Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.



Principal Display Panel




Levocetirizine Dihydrochloride Tablets USP 5 mg-35's Container carton
 
Compare to XYZAL® Allergy 24HR Active Ingredient*

Allergy Relief

Levocetirizine Dihydrochloride
Tablets, USP

5 mg

Antihistamine

24 HOUR Relief of

  • Sneezing
  • Runny Nose
  • Itchy Nose or Throat
  • Itchy, Watery Eyes

    • Original Prescription Strength

    35 TABLETS

    carton - carton

    carton - carton



    Levocetirizine Dihydrochloride Tablets USP 5 mg - 35's Container label

     

    Compare to XYZAL® Allergy 24HR Active Ingredient*

    Allergy Relief

    Levocetirizine Dihydrochloride
    Tablets, USP

    5 mg

    Antihistamine

    24 HOUR Relief of
    •Sneezing
    •Runny Nose
    •Itchy Nose or Throat
    •Itchy, Watery Eyes

    Original Prescription Strength

    35 TABLETS



* Please review the disclaimer below.