ropinirole 0.25 mg

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).

glenmark pharmaceuticals inc., usa

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] pain` `[5] diarrhoea` `[6] off label use` `[7] dyspnoea` `[8] headache` `[9] arthralgia` `[10] dizziness`

4 months ago

ROUND WHITE G 2 53

4 months ago

G 2 53 ROUND WHITE

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: • 0.25 mg: white to off-white tablets with ‘2’ over ‘53’ debossed on one side and ‘G’ 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) • 0.5 mg: pale yellow to yellow tablets with ‘2’ over ‘54’ debossed on one side and ‘G’ 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) • 1 mg: pale green to green tablets with ‘2’ over ‘55’ debossed on one side and ‘G’ 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) • 2 mg: pale pink to pink tablets with ‘2’ over ‘56’ debossed on one side and ‘G’ 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) • 3 mg: purple tablets with ‘2’ over ‘57’ debossed on one side and ‘G’ on the other side NDC 68462-257-01 Bottles of 100 with child-resistant closure NDC 68462-257-10 Bottles of 1000 • 4 mg: pale brown to brown tablets with ‘2’ over ‘58’ debossed on one side and ‘G’ on the other side NDC 68462-258-01 Bottles of 100 with child-resistant closure NDC 68462-258-10 Bottles of 1000 • 5 mg: blue tablets with ‘2’ over ‘59’ debossed on one side and ‘G’ 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 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use.

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