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 should be used only for short periods (up to 2 or 3 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 have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
Mylan Pharmaceuticals Inc.
HOW SUPPLIED Cyclobenzaprine Hydrochloride Tablets, USP are available containing 5 mg, 7.5 mg or 10 mg of cyclobenzaprine hydrochloride, USP. The 5 mg tablets are blue film-coated, round, unscored tablets debossed with M on one side of the tablet and 771 on the other side. They are available as follows: NDC 0378-0771-01 bottles of 100 tablets The 7.5 mg tablets are white film-coated, round, unscored tablets debossed with M on one side of the tablet and 761 on the other side. They are available as follows: NDC 0378-0761-01 bottles of 100 tablets The 10 mg tablets are butterscotch yellow film-coated, round, unscored tablets debossed with M on one side of the tablet and 751 on the other side. They are available as follows: NDC 0378-0751-01 bottles of 100 tablets NDC 0378-0751-10 bottles of 1000 tablets Store at 20Â° to 25Â°C (68Â° to 77Â°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED APRIL 2015 CYC:R14
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site