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Label Changes for:

Prevacid (lansoprazole) delayed-release capsules and orally disintegrating tablets

May 2010

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) – May 2010

Use in Specific Populations
  • Prevacid is not effective in patients with symptomatic GERD age 1 month to less than 1 year of age
Patient Counseling Information
  • Prevacid SoluTab delayed-release orally disintegrating tablets should not be broken or cut