Levocetirizine Dihydrochloride Tablet, Film Coated
FDA Label NDC 85766-152

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sportpharm Llc for the product Levocetirizine Dihydrochloride (NDC 85766-152). 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:

Sportpharm LLC

379 Van Ness Ave 1401,

Torrance, CA 90501

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

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