ropinirole 1 mg
1 INDICATIONS AND USAGE Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinsonβs 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 Parkinsonβs disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
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16 HOW SUPPLIED/STORAGE AND HANDLING Each circular, beveled edged, biconvex film-coated tablet contains
ROPINIROLE hydrochloride, USP equivalent to the labeled amount of
ROPINIROLE as follows: β’ 0.25 mg: white to off-white tablets with β2β over β53β debossed on one side and βGβ on the other side NDC 68462-253-01 Bottles of 100 with child-resistant closure NDC 68462-253-10 Bottles of 1000 NDC 68462-253-11 Unit-dose pack of 100 (10 x 10 unit-dose) β’ 0.5 mg: pale yellow to yellow tablets with β2β over β54β debossed on one side and βGβ on the other side NDC 68462-254-01 Bottles of 100 with child-resistant closure NDC 68462-254-10 Bottles of 1000 NDC 68462-254-11 Unit-dose pack of 100 (10 x 10 unit-dose) β’ 1 mg: pale green to green tablets with β2β over β55β debossed on one side and βGβ on the other side NDC 68462-255-01 Bottles of 100 with child-resistant closure NDC 68462-255-10 Bottles of 1000 NDC 68462-255-11 Unit-dose pack of 100 (10 x 10 unit-dose) β’ 2 mg: pale pink to pink tablets with β2β over β56β debossed on one side and βGβ on the other side NDC 68462-256-01 Bottles of 100 with child-resistant closure NDC 68462-256-10 Bottles of 1000 NDC 68462-256-11 Unit-dose pack of 100 (10 x 10 unit-dose) β’ 3 mg: purple tablets with β2β over β57β debossed on one side and βGβ on the other side NDC 68462-257-01 Bottles of 100 with child-resistant closure NDC 68462-257-10 Bottles of 1000 β’ 4 mg: pale brown to brown tablets with β2β over β58β debossed on one side and βGβ on the other side NDC 68462-258-01 Bottles of 100 with child-resistant closure NDC 68462-258-10 Bottles of 1000 β’ 5 mg: blue tablets with β2β over β59β debossed on one side and βGβ on the other side NDC 68462-259-01 Bottles of 100 with child-resistant closure NDC 68462-259-10 Bottles of 1000 NDC 68462-259-11 Unit-dose pack of 100 (10 x 10 unit-dose) Storage Store at 20Β°C to 25Β°C (68Β°F to 77Β°F); excursions permitted to 15Β°C to 30Β°C (59Β°F to 86Β°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use.
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