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FDA Issues New OTC Ingredient Label Rules

Ken Rankin
Published Online: Tuesday, June 1, 2004   [ Request Print ]

OTC drugs containing calcium, magnesium, sodium, or potassium in levels exceeding specific thresholds will be subject to new content labeling and warning requirements, as a result of final rules announced by the FDA. Under the new rules, the labeling of oral OTC drugs containing any of these 4 ingredients must state the amount of the substance in each dose if they contain the following:

  • ??0.5 mg of sodium in a single dose
  • ??0.20 mg of calcium in a single dose
  • ??0.8 mg of magnesium in a single dose
  • ??0.5 mg of potassium in a single dose

Additionally, the rules require warnings on the label to alert people with kidney stones or decreased kidney function due to kidney disease or people who are on sodium-, calcium-,magnesium-, or potassium-restricted diets to consult their doctors before using products for oral ingestion that contain the following:

  • >140 mg of sodium as the maximum daily dose
  • >3.2 g of calcium as the maximum daily dose
  • >600 mg of magnesium as the maximum daily dose
  • >975 mg of potassium as the maximum daily dose

"These new warnings provide an extra level of safety for people who may be especially sensitive to these commonly used OTC ingredients," said Acting FDA Commissioner Lester M. Crawford. "Although these ingredients can generally be used safely and provide benefit to many consumers, people with conditions that put them at risk of side effects need to be aware of the presence of these ingredients."

The new rules took effect on April 23, 2004. OTC drug manufacturers, however, are being given until September 25, 2005, to bring their products into full compliance.

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