ropinirole hydrochloride tablet film coated
1 INDICATIONS AND USAGE Ropinirole Tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). (1.1, 1.2). 1.1 Parkinson's Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
alembic pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Ropinirole Tablets: Each circular, biconvex, film-coated tablet contains ropinirole as follows: 0.25 mg: white tablets debossed with “H” on one side and “121” on other side NDC 62332-030-31 bottle of 100 tablets 0.5 mg: yellow tablets debossed with “H” on one side and “122” on other side NDC 62332-031-31 bottle of 100 tablets 1 mg: green tablets debossed with “H” on one side and “123” on other side NDC 62332-032-31 bottle of 100 tablets 2 mg: peach tablets debossed with “H” on one side and “124” on other side NDC 62332-033-31 bottle of 100 tablets 3 mg: purple tablets debossed with “H” on one side and “125” on other side NDC 62332-034-31 bottle of 100 tablets 4 mg: Pale brown tablets debossed with “H” on one side and “126” on other side NDC 62332-035-31 bottle of 100 tablets 5 mg: blue tablets debossed with “H” on one side and “127” on other side NDC 62332-036-31 bottle of 100 tablets STORAGE: Protect from light and moisture. Close container tightly after each use. Store at controlled room temperature 20°-25°C (68°-77°F) [see USP].
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