Pramipexole dihydrochloride 0.125 MG Oral Tablet Mirapex
1 INDICATIONS AND USAGE MIRAPEX is a non-ergot dopamine agonist indicated for the treatment of: Parkinson’s disease (PD) ( 1.1 ) Moderate-to-severe primary Restless Legs Syndrome (RLS) ( 1.2 ) 1.1 Parkinson's Disease MIRAPEX tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome MIRAPEX tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
boehringer ingelheim pharmaceuticals, inc.
ROUND WHITE BI 83
BI 83 ROUND WHITE
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Mirapex 1 mg
Boehringer Ingelheim Pharmaceuticals, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied MIRAPEX tablets are available as follows: 0.125 mg: white, round, tablet with “BI” on one side and “83” on the reverse side. Bottles of 90 NDC 0597-0183-90 0.25 mg: white, oval, scored tablet with “BI BI” on one side and “84 84” on the reverse side. Bottles of 90 NDC 0597-0184-90 Unit dose packages of 100 NDC 0597-0184-61 0.5 mg: white, oval, scored tablet with “BI BI” on one side and “85 85” on the reverse side. Bottles of 90 NDC 0597-0185-90 Unit dose packages of 100 NDC 0597-0185-61 0.75 mg: white, oval, debossed tablet with “BI” on one side and “101” on the reverse side. Bottles of 90 NDC 0597-0101-90 1 mg: white, round, scored tablet with “BI BI” on one side and “90 90” on the reverse side. Bottles of 90 NDC 0597-0190-90 Unit dose packages of 100 NDC 0597-0190-61 1.5 mg: white, round, scored tablet with “BI BI” on one side and “91 91” on the reverse side. Bottles of 90 NDC 0597-0191-90 Unit dose packages of 100 NDC 0597-0191-61 16.2 Storage and Handling 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. Store in a safe place out of the reach of children.
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