potassium citrate 10 MEQ Extended Release Oral Tablet
1 INDICATIONS AND USAGE Potassium Citrate extended-release tablets are a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones ( 1.1 ) Hypocitraturic calcium oxalate nephrolithiasis of any etiology ( 1.2 ) Uric acid lithiasis with or without calcium stones ( 1.3 ) 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies ( 14.1 )]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies ( 14.2 )]. 1.3 Uric Acid Lithiasis with or without Calcium Stones Potassium citrate is indicated for the management of uric acid lithiasis with or without calcium stones [see Clinical Studies ( 14.3 )].
actavis pharma, inc.
OVAL YELLOW A94
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16 HOW SUPPLIED/STORAGE AND HANDLING
POTASSIUM CITRATE extended-release tablets USP, 5 mEq are tan to yellowish, speckled, uncoated, round shaped tablets, debossed with “A67” on one side and plain on the other side, supplied in bottles of 100 (NDC 0591-2682-01).
POTASSIUM CITRATE extended-release tablets USP, 10 mEq are tan to yellowish, speckled, uncoated, modified capsule shaped tablets, debossed with “A94” on one side and plain on the other side supplied in bottles of 100 (NDC 0591-2729-01).
POTASSIUM CITRATE extended-release tablets USP, 15 mEq are tan to yellowish, speckled, uncoated, modified oval shaped tablets, debossed with “A96” on one side and plain on the other side, supplied in bottles of 100 (NDC 0591-2742-01). Storage: Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Store in a tight container.
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