Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Tylenol Arthritis Extended Relief Caplets

This article was originally published in The Tan Sheet

Executive Summary

McNeil relaunching Tylenol Extended Relief under new name; the renamed acetaminophen product, slated to ship before August, was promoted to the trade at the NACDS Marketplace show in Philadelphia June 28-July 1. Original Tylenol Extended Relief, marketed under an approved NDA, was introduced in 1994. The analgesic contains 650 mg acetaminophen and employs a bi-layer system for the eight-hour time-release mechanism. Indications on a label mock-up read: "For the temporary relief of the minor pain of arthritis, and the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, for the pain of menstrual cramps and for the reduction of fever." The product is not covered by Waxman/Hatch exclusivity; several patents covering "oral sustained release acetaminophen formulation and process" expire in 2007. Tylenol Extended Relief is sold in three SKUs: a 24-count retails for about $3.70, a 50-count for $5.70 and a 100-tablet bottle for about $8.40. The repositioning appears to follow a growing trend toward indication specific OTCs; Bristol-Myers Squibb recently introduced Excedrin Migraine for relief of mild to moderate pain associated with migraine headache ("The Tan Sheet" Jan. 19, pp. 1-5)...

You may also be interested in...


Private label manufacturer preparing to launch extended-release acetaminophen in anticipation FDA will approve its ANDA by year end. Promotional material at the PLMA annual trade show in Chicago compares the 650 mg pain reliever/fever reducer "to the active ingredient in Tylenol Arthritis." In July 1998, McNeil relaunched Tylenol Extended Relief under the name Tylenol Arthritis Extended Relief Caplets (1"The Tan Sheet" July 6, 1998, p. 18). Allegan, Mich.-based Perrigo also expects agency approval of its ANDA for 5% minoxidil topical solution "well before" Pharmacia & Upjohn's three-year marketing exclusivity expires Nov. 14, 2000. Alpharma's ANDA for private label Rogaine Extra Strength for Men was tentatively approved July 22 (2"The Tan Sheet" Aug. 2, In Brief)

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts