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Label Changes for:

Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets

October 2008

Changes have been made to the PRECAUTIONS sections of the safety label.

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


  • Pregnancy
    • Teratogenic effects
  • Pediatric Use
    • Initial Paragraph
      • ...Prevacid was not effective in patients with symptomatic GERD 1 month to less than 1 year of age in a multicenter...
        double-blind, placebo controlled study.
    • Neonate to less than 1 year of age (new)


  • Carcinogenesis, Mutagenesis, Impairment of Fertility