pramipexole dihydrochloride 0.375 mg
1 INDICATIONS AND USAGE Pramipexole dihydrochloride extended- release tablet is a non-ergot dopamine agonist indicated for the treatment of Parkinson's disease (PD) ( 1 ) Pramipexole dihydrochloride extended- release tablets are indicated for the treatment of Parkinson's disease.
ingenus pharmaceuticals, llc
ROUND WHITE P11 0 375
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
PRAMIPEXOLE DIHYDROCHLORIDE extended- release tablets are available as follows: 0.375 mg: white or off-white, round, biconvex tablets debossed "0.375" on one side and "P11" on the other side. Unit of Use Bottles of 30 NDC 50742-331-30 0.75 mg: white or off-white, round, biconvex tablets debossed "0.75" on one side and "P12" on the other side. Unit of Use Bottles of 30 NDC 50742-332-30 1.5 mg: white or off-white, oval, biconvex tablets debossed "1.5" on one side and "P13" on the other side. Unit of Use Bottles of 30 NDC 50742-333-30 2.25 mg: white or off-white, oval, biconvex tablets debossed "2.25" on one side and "P14" on the other side. Unit of Use Bottles of 30 NDC 50742-334-30 3 mg: white or off-white, oval, biconvex tablets debossed "3.0" on one side and "P15" on the other side. Unit of Use Bottles of 30 NDC 50742-335-30 3.75 mg: white or off-white, oval, biconvex tablets debossed "3.75" on one side and "P16" on the other side. Unit of Use Bottles of 30 NDC 50742-336-30 4.5 mg: white or off-white, oval, biconvex tablets debossed "4.5" on one side and "P17" on the other side. Unit of Use Bottles of 30 NDC 50742-337-30 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° 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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