Cyclobenzaprine hydrochloride 10 MG Oral Tablet

INDICATIONS AND USAGE Cyclobenzaprine HCl 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 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 has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

redpharm drug inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] nausea` `[5] headache` `[6] off label use` `[7] arthralgia` `[8] dyspnoea` `[9] vomiting` `[10] diarrhoea`

5 years ago

ROUND YELLOW Pliva 563

5 years ago

Pliva 563 ROUND YELLOW

HOW SUPPLIED Cyclobenzaprine Hydrochloride Tablets, USP: 10 mg yellow, round, unscored, film-coated tablets in bottles of 100, 500 and 1000. debossed: PLIVA 563 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured in Poland By: PLIVA ® Krakow Pharmaceutical Company S.A. Krakow, Poland Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. A 4/2010 11001643

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