baclofen tablet
INDICATIONS AND USAGE Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.
amneal pharmaceuticals of new york llc
ROUND WHITE C21
C21 ROUND WHITE
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baclofen tablet
amneal pharmaceuticals of new york llc
baclofen tablet
amneal pharmaceuticals of new york llc
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HOW SUPPLIED
BACLOFEN Tablets USP, 5 mg are available as a white, oval shaped, uncoated tablets, debossed with “C19” on one side and plain on other side. Bottle of 100: NDC 0115-1011-01
BACLOFEN Tablets USP, 10 mg are available as an off-white, to beige, round, flat-faced tablet with a beveled edge debossed with a “C21” on top of bisect on one side and plain on the other side. Bottles of 30: NDC 0115-1010-08 Bottles of 100: NDC 0115-1010-01 Bottles of 500: NDC 0115-1010-02 Bottles of 1000: NDC 0115-1010-03
BACLOFEN Tablets USP, 20 mg are available as an off-white, to beige, round, flat-faced tablet with a beveled edge debossed with a “C22” on top of bisect on one side and plain on the other side. Bottles of 30: NDC 0115-1012-08 Bottles of 100: NDC 0115-1012-01 Bottles of 500: NDC 0115-1012-02 Bottles of 1000: NDC 0115-1012-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly-closed, light-resistant container as defined in the USP using a child-resistant closure. Keep this and all medications out of the reach of children. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.04-2021-02
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