December 1, 2015
Recommended Topic Related To:


"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...


How Supplied


TIVORBEX is indicated for treatment of mild to moderate acute pain in adults.


Initial Dosing

For treatment of mild to moderate acute pain, the dosage is 20 mg three times daily or 40 mg two or three times daily. Usethe lowest effective dose for the shortest duration consistent with individual patient treatment goals.


Dosage Forms And Strengths

TIVORBEX (indomethacin) Capsules 20 mg – dark blue body and light blue cap (imprinted IP-201 on the body and 20 mg on the cap in white ink).

TIVORBEX (indomethacin) Capsules 40 mg – dark blue body and blue cap (imprinted IP202 on the body and 40 mg on the cap in white ink).

Storage And Handling

TIVORBEX (indomethacin) are supplied as:

20 mg, NDC (42211-201-23), Bottles of 30 capsules
20 mg, NDC (42211-201-29), Bottles of 90 capsules
40 mg, NDC (42211-202-23), Bottles of 30 capsules
40 mg, NDC (42211-202-29), Bottles of 90 capsules


Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). [see USP Controlled Room Temperature].

Store in the original container and keep the bottle tightly closed to protect from moisture and light. Dispense in a tight container if package is subdivided.

Manufactured (under license from iCeutica Pty Ltd) for and Distributed by: Iroko Pharmaceuticals, LLC One Kew Place 150 Rouse Boulevard Philadelphia, PA 19112. Issued: February 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/5/2014

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Chronic Pain/Back Pain

Find tips and advances in treatment.