Levocetirizine Dihydrochloride Tablet, Film Coated
FDA Label NDC 69230-321

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Camber Consumer Care Inc for the product Levocetirizine Dihydrochloride (NDC 69230-321). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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


    Bottle Label (Bottle Label)

    Bottle Label (Bottle Label)

* Please review the disclaimer below.