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Article: FDA adds new over-the-counter labeling rules: four ingredients.(Rx)(calcium, magnesium, sodium, and potassium )(Brief Article)
- Article from:
- Family Practice News
- Article date:
- June 1, 2004
- Author:
CopyrightCOPYRIGHT 2004 International Medical News Group. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Oral over-the-counter drugs containing specific levels of calcium, magnesium, sodium, or potassium must now include the amount of these ingredients in the labeling, according to the Food and Drug Administration.
The change is aimed at warning patients with underlying medical conditions that require monitoring of these components.
The new FDA rules require oral over-the-counter medications containing these ingredients to state the amount of each in a single dose if the product contains:
* Five mg or more of sodium in a single dose.
* Twenty mg or more of calcium in a single dose.
* Eight mg or more of magnesium in a single ...