FLEXERIL is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.

FLEXERIL should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.

FLEXERIL has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

For most patients, the recommended dose of FLEXERIL is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day. Use of FLEXERIL for periods longer than two or three weeks is not recommended. (see INDICATIONS AND USAGE).

Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly).

FLEXERIL tablets are available in 5 mg and 10 mg dosage strengths. The 5 mg tablets are yellow-orange, 5-sided D-shaped, film coated tablets, coded FLEXERIL on one side and without coding on the other. The 10 mg tablets are butterscotch yellow, 5-sided D-shaped, film coated tablets, coded MSD 931 on one side and FLEXERIL on the other. The two dosage strengths are supplied as follows:

5 mg 30 count carton NDC 50580-280
(5 blister cards, each with 6 tablets)

10 mg 100 count bottle NDC 50580-874-1
100 count unit dose package NDC 50580-874-2
(each tablet individually sealed)

STORAGE

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

Rx Only
Manufactured by : Merck & Co. Inc., West Point, PA 19486, USA.
Distributed and Marketed by : McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA 19034
[McNeil Consumer & Specialty Pharmaceuticals LOGO] [Identification number]
FLEXERIL is a registered trademark of ALZA Corporation
Copyright @ALZA Corporation, 2001
All rights reserved.
FDA rev date: 2/3/2003

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