Document Detail

Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule.
MedLine Citation:
PMID:  17450664     Owner:  HSR     Status:  MEDLINE    
The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (OTC) laxative drug products in granular dosage form containing the bulk-forming psyllium ingredients (psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed) are not generally recognized as safe and effective (GRASE) and are misbranded. This final rule includes, but is not limited to, any granules that are swallowed dry prior to drinking liquid; dispersed, suspended, or partially dissolved in liquid prior to swallowing; chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid; or sprinkled over food. FDA is issuing this final rule after considering reports of esophageal obstruction associated with the use of psyllium laxatives in granular dosage form. These cases continue to occur despite efforts to promote safe use through label warnings and directions. This final rule does not apply to psyllium laxatives in nongranular dosage forms, such as powders, tablets, or wafers. This final rule is part of FDA's ongoing review of OTC drug products.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  72     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2007 Mar 
Date Detail:
Created Date:  2007-04-23     Completed Date:  2007-05-01     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  14669-74     Citation Subset:  T    
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MeSH Terms
Cathartics / adverse effects*,  therapeutic use
Consumer Product Safety
Drug Labeling / legislation & jurisprudence
Nonprescription Drugs / administration & dosage,  adverse effects,  therapeutic use
Psyllium / administration & dosage,  adverse effects*,  therapeutic use
United States
Reg. No./Substance:
0/Cathartics; 0/Nonprescription Drugs; 8063-16-9/Psyllium

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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