1 INDICATIONS & USAGE Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

Potassium chloride extended-release tablets are a potassium salt, indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

(1)

6 ADVERSE REACTIONS The following adverse reactions have been identified with use of oral potassium salts.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.

There have been reports hyperkalemia and of upper and lower gastrointestinal condition including obstruction, bleeding, ulceration, perforation.

Skin rash has been reported rarely.

• The most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc.

at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch