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Label Changes for:

Opana ER (oxymorphone hydrochloride extended-release) Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg

January 2013

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

 

January 2013

17 PATIENT COUNSELING INFORMATION

Important Administration Instructions
  • Occasionally, the inactive ingredients of OPANA ER may be eliminated as a soft mass in the stool that may resemble the original tablet. Patients should be informed that the active medication has already been absorbed by the time the patient sees the soft mass
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