Table of Contents

DERAMAXX
Equioxx®
EtoGesic®
Metacam®
Novox®
Previcox
Rimadyl®
SURPASS
Zubrin

This page contains a partial collection of the labeling that has been submitted to the FDA Center for Veterinary Medicine (FDA CVM) by veterinary product sponsors. The labeling includes product information for veterinary professionals (Package Inserts - PI) and for animal owners (Client Information Sheets – CIS). Information in the labeling includes the indications for use, dosage form, route of administration, and the recommended dosage.

Please be advised several hyper-links leave the FDA/CVM.gov domain and connect to external sponsor Websites. These links provide access to labeling that could not be posted on a .gov domain due to technical difficulties. However, while the information was accurate at the time of posting and was consistent with the intended purpose of the FDA CVM Web site, FDA CVM cannot attest to the accuracy of information provided by these external links or any other externally linked site. In addition, providing links to a non-FDA Web site does not constitute an endorsement by FDA or CVM or any of its employees of the sponsors of the site or the information or products presented on the site. Also, be aware that the privacy protection provided on the FDA.gov domain (see Privacy Statement and Other Information About FDA’s Website) may not be available at the external link.

If the product labeling you require is not electronically available, please submit a written Freedom of Information Act (FOIA) request. Information on how to submit an FOIA request can be found in "A Handbook for Requesting Information and Records from FDA".  CVM can not accept FOI requests via E-mail.

• CVM Update - FDA Seeks Comment on the Electronic Distribution of Prescribing Information for Prescription Animal Drug Products, October 22, 2007

• Federal Register Notice - Docket No. 2007N-0114, OC 2007236. Electronic Distribution of Prescribing Information for Prescription Drug Products; Reopening of Comment Period. Pages 59536-59537 [FR Doc. E7-20759] October 22, 2007 | htm | | pdf | | Pre-Pub | Comments due December 6, 2007

In addition, you can access the Websites of drug sponsors for labeling information.

Documents in PDF format require the use of Adobe Acrobat Reader. Click the hyperlink text for easy downloading instructions.

DERAMAXX^TM

• DERAMAXX Chewable Tablets, NADA 141-203, Client Information Sheet, 2006 (pdf)

• DERAMAXX Chewable Tablets, NADA 141-203, Package Insert, January 2006 (pdf)

Equioxx®

• Equioxx® Oral Paste, NADA 141-253, Client Information Sheet, February 2006 (pdf)

• Equioxx® Oral Paste, NADA 141-253, Package Insert, February 2006 (pdf)

EtoGesic®

• EtoGesic® Tablets, NADA 141-108, Client Information Sheet, March 2001 (pdf)

• EtoGesic® Tablets, NADA 141-108, Package Insert, 2004 (pdf)

Metacam®

• Metacam 0.5 mg/mL Oral Suspension, NADA 141-213, Client Information Sheet, August 2006 (pdf)

• Metacam 0.5 mg/mL Oral Suspention, NADA 141-213, Package Insert, August 2006 (pdf)

• Metacam 1.5 mg/mL Oral Suspension, NADA 141-213, Client Information Sheet, January 2005 (pdf)

• Metacam 1.5 mg/mL Oral Suspension, NADA 141-213, Package Insert, January 2005 (pdf)

• Metacam 0.5 mg/mL Solution for Injection, NADA 141-219, Package Insert, October 2004(pdf)

Novox®

• Novox Caplets, NADA 200-366, Client Information Sheet, June 2005 (pdf)

• Novox Caplets, NADA 200-366, Package Insert, September 2005 (pdf)

Previcox®

• Previcox Chewable Tablets, NADA 141-230, Client Information Sheet, 2007(pdf)

• Previcox Chewable Tablets, NADA 141-230, Package Insert, 2007 (pdf)

Rimadyl®

• RIMADYL® Caplets, NADA 141-053, Client Information Sheet, January 2004 (pdf)

• RIMADYL® Caplets, NADA 141-053, Package Insert, January 2004 (pdf)

• RIMADYL® Chewable Tablets, NADA 141-111, Client Information Sheet, January 2004 (pdf)

• RIMADYL® Chewable Tablets, NADA 141-111, Package Insert, January 2004 (pdf)

• RIMADYL® Sterile Injectable Solution, NADA 141-199, Package Insert, September 2005 (pdf)

SURPASS^TM

• SURPASS, NADA 141-186, Client Information Sheet & Package Insert, 2004 (pdf)

Zubrin^TM

• Zubrin Rapidly-Disintegrating Tablets, NADA 141-193, Client Information Sheet, April 2004 (pdf)

• Zubrin Rapidly-Disintegrating Tablets, NADA 141-193, Package Insert, 2002 (pdf)
  (The above link leaves the FDA web. FDA is not responsible for the contents of any off-site Internet information referenced by or linked to the agency's internet site.)

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