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Article | August 31, 1998
FDA to streamline dietary supplement labels (sidebar)
FDA 'dumps' laxative package
The FDA forced a venerable name in laxatives to dump one of its packages and add new labeling to two other packages. The C.B. Fleet Co. Inc. Lynchburg VA was required to pull its 240-mL packages of sodium phosphate oral laxatives off the market by July 22. Cheryl Turner an FDA official says there are a number of generic marketers who will also have to discontinue their 240-mL package. Packages containing 45 ml and 90 mL can stay on the market but they will have to include new label language by October 22. Enema products will have to carry new label language too by that deadline. Sodium phosphate laxatives are used mostly by the elderly prior to a colonoscopy. Other liquid laxatives that are typically used for constipation such as those containing citrate of magnesia or those sold by Diamond Products Seffner FL under the Castor Oil brand are unaffected. The standard dose for bowel cleansing prior to a colonoscopy is 45 mL. But the FDA got reports that some elderly consumers died after taking overdoses of sodium phosphate products ostensibly drinking the entire contents of a 240-mL container. There have been no reports that downing 90 mL in one shot has seriously hurt anyone. The new warning for containers of 45 mL or 90 mL must say: "Taking more than the recommended dose in 24 hours can be harmful." For rectal sodium phosphates drug products better known as enemas the warning will say: "Using more than one enema in 24 hours can be harmful."
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