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Label Changes for:

Levothyroxine Sodium Tablets, USP

June 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) -- 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


  • Information for Patients
    • ...It is very important that you take the tablet with a full glass of water.
    • Agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine sodium tablets...
  • Drug Interactions
    • Table 2: Drug-Thyroidal Axis Interactions
      • Drugs that may decrease T4 absorption, which may result in hypothyroidism
        • Orlistat

Label not available on Drugs@FDA