ropinirole 0.5 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).
bionpharma inc.
OVAL YELLOW RH 106
RH 106 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING Each modified oval shaped, biconvex film-coated tablet contains
ROPINIROLE hydrochloride, USP equivalent to the labeled amount of
ROPINIROLE as follows: 0.25 mg: white to off white coloured, modified oval shaped, biconvex, film-coated tablet debossed with “105” on one side and “RH” on the other side in bottles of 100 (NDC 69452-356-20), with a child-resistant closure. 0.5 mg: pale yellow coloured, modified oval shaped, biconvex, film-coated tablet debossed with “106” on one side and “RH” on the other side in bottles of 100 (NDC 69452-357-20), with a child-resistant closure. 1 mg: pale green coloured, modified oval shaped, biconvex, film-coated tablet debossed with “107” on one sideand “RH” on the other side in bottles of 100 (NDC 69452-358-20), with a child-resistant closure. 2 mg: pink coloured, modified oval shaped, biconvex, film-coated tablet debossed with “110” on one side and “RH” on the other side in bottles of 100 (NDC 69452-359-20), with a child-resistant closure. 3 mg: purple coloured, modified oval shaped, biconvex, film-coated tablet debossed with “112” on one side and “RH” on the other side in bottles of 100 (NDC 69452-360-20), with a child-resistant closure. 4 mg: brown coloured, modified oval shaped, biconvex, film-coated tablet debossed with “114” on one side and “RH” on the other side in bottles of 100 (NDC 69452-361-20), with a child-resistant closure. 5 mg: pale blue coloured, modified oval shaped, biconvex, film-coated tablet debossed with “115” on one side and“RH” on the other side in bottles of 100 (NDC 69452-362-20), with a child-resistant closure. Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use.
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