Cyclobenzaprine 5 mg
INDICATIONS AND USAGE Cyclobenzaprine HCl tablets are 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. Cyclobenzaprine HCl tablets 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. Cyclobenzaprine HCl tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
Breckenridge Pharmaceutical, Inc.
ROUND ORANGE TL 211
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HOW SUPPLIED Cyclobenzaprine HCl Tablets, USP are available in the following strengths and package sizes: 5 mg (orange, round, film-coated, debossed with TL211 on one side and plain on the other side) Bottles of 100's NDC 51991-467-01 Bottles of 1000's NDC 51991-467-10 10 mg (yellow, round, film-coated, debossed with TL177 on one side and plain on the other side) Bottles of 100's NDC 51991-468-01 Bottles of 1000's NDC 51991-468-10 Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].
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