Pramipexole dihydrochloride 1.5 MG Oral Tablet
1 INDICATIONS AND USAGE Pramipexole dihydrochloride tablets are 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).
zydus pharmaceuticals (usa) inc.
ROUND YELLOW P5
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 0.125 mg are pink color, capsule-shaped, flat, beveled-edged, uncoated tablets debossed with 'P1'on one side and plain on other side and are supplied are as follows: NDC 68382-196-16 in bottle of 90 tablets NDC 68382-196-05 in bottle of 500 tablets NDC 68382-196-10 in bottle of 1000 tablets
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 0.25 mg are pale blue color, round, flat, beveled-edged, uncoated tablets debossed with 'P2'on one side and break line on other side and are supplied as follows: NDC 68382-197-16 in bottle of 90 tablets NDC 68382-197-05 in bottle of 500 tablets NDC 68382-197-10 in bottle of 1000 tablets
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 0.5 mg are Lavender, capsule-shaped, flat, beveled-edged, uncoated tablets debossed with 'P' break line '3' on one side and plain on other side and are supplied as follows: NDC 68382-198-16 in bottle of 90 tablets NDC 68382-198-05 in bottle of 500 tablets NDC 68382-198-10 in bottle of 1000 tablets
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 0.75 mg are light peach color capsule shaped, flat, beveled-edged, uncoated tablets debossed with '440' on one side and plain on other side and are supplied as follows: NDC 68382-440-16 in bottle of 90 tablets NDC 68382-440-05 in bottle of 500 tablets NDC 68382-440-10 in bottle of 1000 tablets
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 1 mg are light peach to peach, round, flat, beveled-edged, uncoated tablets debossed with 'P4'on one side and break line on other side and are supplied as follows: NDC 68382-199-16 in bottle of 90 tablets NDC 68382-199-05 in bottle of 500 tablets NDC 68382-199-10 in bottle of 1000 tablets
PRAMIPEXOLE DIHYDROCHLORIDE Tablets, 1.5 mg are yellow color, round, flat, beveled- edged, uncoated tablets debossed with 'P5'on one side and break line on other side and are supplied as follows: NDC 68382-200-16 in bottle of 90 tablets NDC 68382-200-05 in bottle of 500 tablets NDC 68382-200-10 in bottle of 1000 tablets 16.2 Storage and Handling Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container. Store in a safe place out of the reach of children.
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