Ropinirole ropinirole 0.5 MG Oral Tablet

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 is indicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

Roxane Laboratories, Inc

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

6 years ago

ROUND YELLOW 54 337

16 HOW SUPPLIED/STORAGE AND HANDLING rOPINIRole Tablets, USP The 0.25 mg tablet is supplied as a white to off-white, round biconvex tablet, debossed with “54 511” on one side and plain on the other side. NDC 0054-0116-25: Bottle of 100 Tablets The 0.5 mg tablet is supplied as a yellow to speckled-yellow, round biconvex tablet, debossed with “54 337” on one side and plain on the other side. NDC 0054-0117-25: Bottle of 100 Tablets The 1 mg tablet is supplied as a green to speckled-green, round biconvex tablet, debossed with “54 751” on one side and plain on the other side. NDC 0054-0118-25: Bottle of 100 Tablets The 2 mg tablet is supplied as an orange to speckled-orange, round biconvex tablet, debossed with “54 231” on one side and plain on the other side. NDC 0054-0119-25: Bottle of 100 Tablets The 3 mg tablet is supplied as a red to speckled-red, round biconvex tablet, debossed with “54 575” on one side and plain on the other side. NDC 0054-0120-25: Bottle of 100 Tablets The 4 mg tablet is supplied as a brown to speckled-brown, round biconvex tablet, debossed with “54 273” on one side and plain on the other side. NDC 0054-0121-25: Bottle of 100 Tablets The 5 mg tablet is supplied as a blue to speckled-blue, round biconvex tablet, debossed with “54 722” on one side and plain on the other side. NDC 0054-0122-25: Bottle of 100 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Close container tightly after each use.

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