24 HR Cyclobenzaprine hydrochloride 15 MG Extended Release Oral Capsule
1 INDICATIONS AND USAGE Cyclobenzaprine hydrochloride extended-release capsules 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, and limitation of motion. Limitations of Use: Cyclobenzaprine hydrochloride extended-release capsules 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 extended-release capsules have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy. Cyclobenzaprine hydrochloride extended-release capsules are a muscle relaxant indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. (1) Limitations of Use: Cyclobenzaprine hydrochloride extended-release capsules should be used only for short periods (up to 2 or 3 weeks) (1) Cyclobenzaprine hydrochloride extended-release capsules have not been found effective in the treatment of spasticity or cerebral palsy (1)
apotex corp.
CAPSULE ORANGE APO C15
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Cyclobenzaprine hydrochloride extended-release capsules, USP are available in 15 and 30 mg strengths. Cyclobenzaprine hydrochloride extended-release capsules, USP 15 mg are hard gelatin capsules with orange opaque body, orange opaque cap, imprinted "APO C15" in white ink and filled with white to off-white, round, biconvex tablets. They are supplied as follows: Bottles of 60 capsules NDC 60505-3972-6 Cyclobenzaprine hydrochloride extended-release capsules, USP 30 mg are hard gelatin capsules with standard red opaque body, dark blue opaque cap, imprinted "APO C30" in white ink and filled with white to off-white, round, biconvex tablets. They are supplied as follows: Bottles of 60 capsules NDC 60505-3973-6 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP].
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