24 HR Pramipexole dihydrochloride 3.75 MG Extended Release Oral Tablet Mirapex
1 INDICATIONS AND USAGE MIRAPEX ER ® tablets are indicated for the treatment of Parkinson's disease. MIRAPEX ER is a non-ergot dopamine agonist indicated for the treatment of Parkinson's disease (PD) ( 1 )
Boehringer Ingelheim Pharmaceuticals, Inc.
OVAL WHITE ER 3 75
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied MIRAPEX ER tablets are available as follows: 0.375 mg: white to off-white, round, bevel-edged, extended-release tablets debossed with "ER" on one side and "0.375" on the other side. Unit of Use Bottles of 7 NDC 0597-0109-17 Unit of Use Bottles of 30 NDC 0597-0109-30 0.75 mg: white to off-white, round, bevel-edged, extended-release tablets debossed with "ER" on one side and "0.75" on the other side. Unit of Use Bottles of 7 NDC 0597-0285-17 Unit of Use Bottles of 30 NDC 0597-0285-30 1.5 mg: white to off-white, oval, extended-release tablets debossed with "ER" on one side and "1.5" on the other side. Unit of Use Bottles of 7 NDC 0597-0113-17 Unit of Use Bottles of 30 NDC 0597-0113-30 2.25 mg: white to off-white, oval, extended-release tablets debossed with "ER" on one side and "2.25" on the other side. Unit of Use Bottles of 30 NDC 0597-0286-30 3 mg: white to off-white, oval, extended-release tablets debossed with "ER" on one side and "3.0" on the other side. Unit of Use Bottles of 30 NDC 0597-0115-30 3.75 mg: white to off-white, oval, extended-release tablets debossed with "ER" on one side and "3.75" on the other side. Unit of Use Bottles of 30 NDC 0597-0287-30 4.5 mg: white to off-white, oval, extended-release tablets debossed with "ER" on one side and "4.5" on the other side. Unit of Use Bottles of 30 NDC 0597-0116-30 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from exposure to high humidity. Store in a safe place out of the reach of children.
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