Label Changes for:

Valtrex (valacyclovir hydrochloride) Caplets

September 2008

Changes have been made to the ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

ADVERSE REACTIONS

  • Clinical Trials Experience in Pediatric Patients

USE IN SPECIFIC POPULATIONS

  • Pediatric Use

PATIENT COUNSELING INFORMATION

  • Chickenpox
    • Patients should be advised to initiate treatment at the earliest sign or symptom of chickenpox.

PATIENT PACKAGE INSERT

  • What is Valtrex?
    • Valtrex is used in children:
      • ...to treat chickenpox (for children 2 to <18 years of age).
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