Pramipexole dihydrochloride 0.5 MG Oral Tablet

1 INDICATIONS AND USAGE Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of: • Parkinson’s disease (PD) ( 1.1 ) 1.1 Parkinson's Disease Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease.

Sandoz Inc

FDA Reported Adverse Reactions
`[1] fatigue` `[2] nausea` `[3] drug ineffective` `[4] dyspnoea` `[5] diarrhoea` `[6] off label use` `[7] pain` `[8] headache` `[9] dizziness` `[10] vomiting`

4 years ago

OVAL WHITE SZ 17 5

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Pramipexole dihydrochloride tablets are available as follows: 0.125 mg, white to off-white, uncoated, round shaped tablets, one side debossed with ‘SZ’ and other side debossed with ‘173’. NDC 0781-5248-92, bottle of 90 tablets NDC 0781-5248-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 0.25 mg, white to off-white, uncoated, oval shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side debossed with ‘17’& ‘4’ on either side of scoreline. NDC 0781-5249-31, bottle of 30 tablets NDC 0781-5249-60, bottle of 60 tablets NDC 0781-5249-92, bottle of 90 tablets NDC 0781-5249-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 0.5 mg, white to off-white, uncoated, oval shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side debossed with ‘17’ & ‘5’ on either side of scoreline. NDC 0781-5250-31, bottle of 30 tablets NDC 0781-5250-60, bottle of 60 tablets NDC 0781-5250-92, bottle of 90 tablets NDC 0781-5250-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 0.75 mg, white to off-white, uncoated, oval shaped tablets, one side debossed with ‘SZ’ and other side debossed with ‘178’. NDC 0781-5281-31, bottle of 30 tablets NDC 0781-5281-60, bottle of 60 tablets NDC 0781-5281-92, bottle of 90 tablets NDC 0781-5281-13, in unit-of-use pack of 100 tablets (10 blister card, containing 10 tablets) 1 mg, white to off-white, uncoated, round shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side side debossed with ‘17’ & ‘6’ on either side of scoreline. NDC 0781-5251-31, bottle of 30 tablets NDC 0781-5251-60, bottle of 60 tablets NDC 0781-5251-92, bottle of 90 tablets NDC 0781-5251-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 1.5 mg, white of off-white, uncoated, round shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side debossed with ‘17’ & ‘7’ on either side of scoreline. NDC 0781-5252-31, bottle of 30 tablets NDC 0781-5252-60, bottle of 60 tablets NDC 0781-5252-92, bottle of 90 tablets NDC 0781-5252-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 16.2 Storage and Handling Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.

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