Pramipexole dihydrochloride Pramipexole dihydrochloride 0.25 MG Oral Tablet
1 INDICATIONS & USAGE Pramipexole dihydrochloride tablets are 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 Pramipexole dihydrochloride tablets are indicated for the treatment Parkinson's disease. 1.2 Restless Legs Syndrome Pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
Macleods Pharmaceuticals Limited
OVAL WHITE CL 3
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Pramipexole dihydrochloride tablets are available as follows: 0.125 mg: white coloured, circular, flat, beveled edged uncoated tablet debossed 'CL' on one side of the tablet and '2' on the other side. Bottles of 90's NDC 33342-031-10 Bottles of 500's NDC 33342-031-15 Unit dose blister Pack of 30's NDC 33342-031-06 Unit dose blister pack of 100's NDC 33342-031-12 0.25 mg: white coloured, oval shaped, uncoated tablet with 'CL' and '3' debossed on one side of the tablet with breakline separating 'CL' and '3' and having a breakline on the other side. Bottles of 90's NDC 33342-032-10 Bottles of 500's NDC 33342-032-15 Unit dose blister pack of 30's NDC 33342-032-06 Unit dose blister pack of 100's NDC 33342-032-12 0.5 mg: white coloured, oval shaped, uncoated tablet with 'CL' and '4' debossed on one side of the tablet with breakline separating 'CL' and '4' and having a breakline on the other side. Bottles of 90's NDC 33342-033-10 Bottles of 500's NDC 33342-033-15 Unit dose blister pack of 30's NDC 33342-033-06 Unit dose blister pack 100's NDC 33342-033-12 1 mg: white coloured, flat, circular, beveled edged uncoated tablet with 'CL' and '5' debossed on one side of the tablet with breakline separating 'CL' and '5' and having a breakline on the other side. Bottles of 90's NDC 33342-034-10 Bottles of 500's NDC 33342-034-15 Unit dose blister pack of 30's NDC 33342-034-06 Unit dose blister pack of 100s NDC 33342-034-12 1.5 mg: white coloured, flat, circular, beveled edged uncoated tablet with 'CL' and '6' debossed on one side of the tablet with breakline separating 'CL' and '6' and having a breakline on the other side. Bottles of 90's NDC 33342-035-10 Bottles of 500's NDC 33342-035-15 Unit dose blister pack of 30's NDC 33342-035-06 Unit dose blister pack of 100's NDC 33342-035-12 16.2 Storage and Handling Store pramipexole dihydrochloride tablet at 20° to 25°C (68° 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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