SPL Set ID: 94ae03cc-b620-0dbb-e053-2a95a90a922c
1 drug(s) with this SPL Set ID
Potassium Chloride Extended-Release Tablets USP are a solid oral dosage form of potassium chloride containing 750 mg and 1,500 mg of potassium chloride, USP, equivalent to 10 mEq and 20 mEq of potassium, respectively, in a film-coated (not enteric-coated), wax matrix tablet. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Each tablet contains the labeled amount of potassium chloride and the following inactive ingredients: colloidal silicon dioxide, hydrogenated vegetable oil, microcrystalline cellulose, polyvinyl acetate, povidone, sodium lauryl sulfate and triethyl citrate. The coating material of 10 mEq (750 mg) product contains ferrosoferric oxide, iron oxide yellow, mono- and di-glycerides, polyethylene glycol polyvinyl alcohol graft copolymer, polyvinyl alcohol, talc and titanium dioxide. The coating material of 20 mEq (1500 mg) product contains hypromellose and talc. FDA approved assay test differs from USP. FDA approved dissolution test specifications differ from USP.