INDICATIONS AND USAGE Cyclobenzaprine hydrochloride tablets, USP 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 hydrochloride tablets, USP 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 hydrochloride tablets, USP have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
Aurobindo Pharma Limited
HOW SUPPLIED Cyclobenzaprine Hydrochloride Tablets USP, 5 mg are yellow-orange, biconvex, 5-sided D-shaped film-coated tablets, debossed with â€˜Dâ€™ and â€˜87â€™ on one side and plain on other side. Bottles of 100 NDC 65862-190-01 Bottles of 500 NDC 65862-190-05 Bottles of 1,000 NDC 65862-190-99 Cyclobenzaprine Hydrochloride Tablets USP, 10 mg are butterscotch yellow, biconvex, 5-sided D-shaped film-coated tablets, debossed with â€˜Dâ€™ and â€˜32â€™ on one side and plain on other side. Bottles of 100 NDC 65862-191-01 Bottles of 500 NDC 65862-191-05 Bottles of 1,000 NDC 65862-191-99 STORAGE Store at 20Â° to 25Â°C (68Â° to 77Â°F); excursions permitted to 15Â° to 30Â°C (59Â° to 86Â°F) [See USP Controlled Room Temperature]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabadâ€“500 038, India Revised: 12/2018
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