Label Changes for:

Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup, Injection

July 2011

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2011

 

5 WARNINGS AND PRECAUTIONS

5.1 Inadvertent Intravenous Administration
  • BENTYL solution is for intramuscular administration only. Do not administer by any other route. Inadvertent intravenous administration may result in thrombosis, thrombophlebitis, and injection site reactions such as pain, edema, skin color change, and reflux sympathetic dystrophy syndrome [see Adverse Reactions (6.2)].
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