Pramipexole 0.5 mg
1 INDICATIONS AND USAGE Pramipexole dihydrochloride tablets are 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 of 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).
Torrent Pharmaceuticals Limited
ROUND BROWN 9 3
9 3 ROUND BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
PRAMIPEXOLE DIHYDROCHLORIDE Tablets are available as follows:
PRAMIPEXOLE DIHYDROCHLORIDE Tablets 0.125 mg are white to off white, round, flat, bevel edged, uncoated tablets with "91" debossed on one side and plain on other side. Bottles of 30 NDC 13668-091-30 Bottles of 90 NDC 13668-091-90 Bottles of 500 NDC 13668-091-05 Bottles of 6,000 NDC 13668-091-42
PRAMIPEXOLE DIHYDROCHLORIDE Tablets 0.25 mg are peach colored, round, flat, bevel edged, uncoated tablets with "9/2" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-092-30 Bottles of 90 NDC 13668-092-90 Bottles of 500 NDC 13668-092-05 Bottles of 5,500 NDC 13668-092-41
PRAMIPEXOLE DIHYDROCHLORIDE Tablets 0.5 mg are reddish brown colored, round, biconvex, uncoated tablets with "9/3" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-093-30 Bottles of 90 NDC 13668-093-90 Bottles of 500 NDC 13668-093-05 Bottles of 4,000 NDC 13668-093-40
PRAMIPEXOLE DIHYDROCHLORIDE Tablets 0.75 mg are yellow colored, round, flat, bevel edged, uncoated tablets with "84" debossed on one side and plain on other side. Bottles of 30 NDC 13668-184-30 Bottles of 90 NDC 13668-184-90 Bottles of 500 NDC 13668-184-05 Bottles of 2,500 NDC 13668-184-31
PRAMIPEXOLE DIHYDROCHLORIDE Tablets 1 mg are light pink colored, round, flat, bevel edged, uncoated tablets with "9/4" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-094-30 Bottles of 90 NDC 13668-094-90 Bottles of 500 NDC 13668-094-05 Bottles of 2,500 NDC 13668-094-31
PRAMIPEXOLE DIHYDROCHLORIDE Tablets 1.5 mg are white to off white, round, flat, bevel edged, uncoated tablets with "9/5" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-095-30 Bottles of 90 NDC 13668-095-90 Bottles of 500 NDC 13668-095-05 Bottles of 1,500 NDC 13668-095-15 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° and 30°C (59° and 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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