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 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).
Mylan Pharmaceuticals Inc.
ROUND YELLOW M N 5
M N 5 ROUND YELLOW
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ropinirole 1 MG Oral Tablet
Mylan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Ropinirole Tablets, USP are available containing ropinirole hydrochloride, USP equivalent to 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg or 5 mg of ropinirole. The 0.25 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and N over 25 on the other side. They are available as follows: NDC 0378-5525-01 bottles of 100 tablets The 0.5 mg tablets are yellow, round, unscored tablets debossed with M on one side of the tablet and N over 5 on the other side. They are available as follows: NDC 0378-5550-01 bottles of 100 tablets The 1 mg tablets are green, round, unscored tablets debossed with M on one side of the tablet and N over 10 on the other side. They are available as follows: NDC 0378-5501-01 bottles of 100 tablets The 2 mg tablets are orange, round, unscored tablets debossed with M on one side of the tablet and N over 20 on the other side. They are available as follows: NDC 0378-5502-01 bottles of 100 tablets The 3 mg tablets are Lavender, round, unscored tablets debossed with M on one side of the tablet and N over 30 on the other side. They are available as follows: NDC 0378-5503-01 bottles of 100 tablets The 4 mg tablets are grayish beige, round, unscored tablets debossed with M on one side of the tablet and N over 40 on the other side. They are available as follows: NDC 0378-5504-01 bottles of 100 tablets The 5 mg tablets are blue, round, unscored tablets debossed with M on one side of the tablet and N over 50 on the other side. They are available as follows: NDC 0378-5505-01 bottles of 100 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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