cyclobenzaprine hydrochloride 10 mg
INDICATIONS AND USAGE Cyclobenzaprine HCl is 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 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.
Teva Pharmaceuticals USA, Inc.
ROUND WHITE TV W53
TV W53 ROUND WHITE
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HOW SUPPLIED
CYCLOBENZAPRINE HYDROCHLORIDE Tablets USP, 5 mg are round, white, unscored, film-coated tablets debossed W51 on one side and TV on the other side and supplied in bottles of 100 (NDC 0093-3420-01).
CYCLOBENZAPRINE HYDROCHLORIDE Tablets USP, 7.5 mg are round, white, unscored, film-coated tablets debossed W52 on one side and TV on the other side and supplied in bottles of 100 (NDC 0093-3421-01).
CYCLOBENZAPRINE HYDROCHLORIDE Tablets USP, 10 mg are round, white, unscored, film-coated tablets debossed W53 on one side and TV on the other side and supplied in bottles of 100 (NDC 0093-3422-01), 500 (NDC 0093-3422-05) and 1000 (NDC 0093-3422-10). Dispense in a well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured In Czech Republic By: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic Manufactured By: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. A 1/2021
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