pramipexole 1 mg
1 INDICATIONS AND USAGE Pramipexole dihydrochloride tablets 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 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).
strides pharma science limited
ROUND WHITE P 5
P 5 ROUND WHITE
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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 to off white colored circular tablets, debossed as 'P1' on one side and plain on other side. Bottles of 90 NDC: 64380-746-05 0.25 mg: white to off white colored, oval tablets, debossed as "P2" on one side with break line on both sides. Bottles of 90 NDC: 64380-747-05 Unit dose pack of 100 (10x10) NDC: 64380-747-01 0.5 mg: white to off white colored, oval shaped tablets, debossed as "P3" on one side with break line on both sides. Bottles of 90 NDC: 64380-748-05 Unit dose pack of 100 (10x10) NDC: 64380-748-01 0.75 mg: white to off white colored, oval shaped tablets, debossed as "P4" on one side plain on other side. Bottles of 90 NDC: 64380-749-05 1 mg: white to off white colored circular tablets, debossed as "P5" on one side and break line on both sides. Bottles of 90 NDC: 64380-750-05 Unit dose pack of 100 (10x10) NDC: 64380-750-01 1.5 mg: white to off white colored circular tablets, debossed as "P6" on one side and break line on both sides. Bottles of 90 NDC: 64380-751-05 Unit dose pack of 100(10x10) NDC: 64380-751-01 16.2 Storage and Handling Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°- 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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