Labeling of Orally Ingested Over-the-Counter Drug Products Containing Calcium, Magnesium, and Potassium

الملخص

The Food and Drug Administration (FDA) is proposing to amend the general labeling provisions for over-the-counter (OTC) drug products to require that the labeling of all OTC drug products intended for oral ingestion include the calcium content per dosage unit when the product contains 20 milligrams (mg) or more per single dose; a warning statement that persons with kidney stones and persons on a calcium- restricted diet should not take the product unless directed by a doctor when the product contains more than 3.2 grams (g) of calcium in the labeled maximum daily dose; the magnesium content per dosage unit when the product contains 8 mg or more per single dose; a warning statement that persons with kidney disease and persons on a magnesium-restricted diet should not take the product unless directed by a doctor if the product contains more than 600 mg magnesium in the labeled maximum daily dose; the potassium content per dosage unit when the product contains 5 mg or more per single dose; and a warning statement that persons with kidney disease and persons on a potassium-restricted diet should not take the product unless directed by a doctor if the product contains more than 975 mg p