pramipexole dihydrochloride 0.5 MG Oral Tablet

1 INDICATIONS AND USAGE Pramipexole dihydrochloride 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).

American Health Packaging

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

12 months ago

ROUND BROWN 9 3

12 months ago

9 3 ROUND BROWN

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

PRAMIPEXOLE DIHYDROCHLORIDE Tablets are available as follows:

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. Unit dose packages of 100 (10 x 10) NDC 60687-570-01

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. Unit dose packages of 30 (3 x 10) NDC 60687-581-21

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. Unit dose packages of 30 (3 x 10) NDC 60687-592-21 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. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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