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U.S. Department of Health and Human Services

Safety

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Aciphex (rabeprazole sodium) Delayed Release Tablets


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


Summary View

Sections Modified

ADVERSE REACTIONS

  • Clinical Studies Experience
    • In a multicenter, open-label study of adolescent patients aged 12 to 16 years...

USE IN SPECIFIC POPULATIONS

  • Pediatric Use

PATIENT PACKAGE INSERT

  • What is Aciphex?
    • Aciphex is used in adolescents 12 years of age and above...