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. |
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).
- Valtrex is used in children:
