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Kaolin is a hydrated aluminum silicate with adsorbent properties. FDA's over-the-counter antidiarrheal monograph M008 lists kaolin as an oral antidiarrheal active ingredient when used within the monograph conditions. The permitted use statement says that kaolin helps firm stool within 24 to 48 hours.
read more about kaolin ...Kaolin acts as an intestinal adsorbent and can bind water and other substances in the gastrointestinal tract. This can increase stool firmness, but it does not treat the underlying cause of infectious diarrhea. Published clinical guidance has found limited evidence for kaolin in infectious gastroenteritis.
The FDA monograph directions apply to adults and children age 12 and older. Children younger than 12 require medical advice before use. People with bloody or black stool do not use a monograph kaolin antidiarrheal, and fever or mucus in the stool requires medical advice before use.
The FDA monograph lists 26.2 g after each loose stool for adults and children age 12 and older, followed by dosing every six hours until stool becomes firm for no more than two days. The monograph limits total intake to 262 g in 24 hours and directs users to drink clear fluids to reduce dehydration risk.
Kaolin can interfere with absorption of other oral medicines, so the FDA monograph directs use at least three hours before or after other drugs. Treatment stops and medical advice is sought if symptoms worsen or diarrhea lasts longer than two days. Fluid replacement remains necessary during diarrhea.
FDA monograph M008 lists kaolin as an over-the-counter antidiarrheal active ingredient under specified conditions.
The permitted use statement says that kaolin helps firm stool within 24 to 48 hours.
The monograph limits treatment to no more than two days.
Yes. The monograph directs users to separate kaolin from other drugs by at least three hours.
Acute Non-Specific Diarrhoea: Studies on the Use of Charcoal, Kaolin-Pectin and Diphenoxylate. https://pubmed.ncbi.nlm.nih.gov/482236/. Date Accessed October 7, 2026.
Antidiarrheal Agents in the Treatment of Acute Diarrhea in Children. https://pubmed.ncbi.nlm.nih.gov/781336/. Date Accessed October 7, 2026.
Kaolin. https://pubchem.ncbi.nlm.nih.gov/compound/Kaolin. Date Accessed October 7, 2026.
OTC Monograph M008: Antidiarrheal Drug Products for Over-the-Counter Human Use. https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTC%20Monograph_M008-Antidiarrheal%20Drug%20Products%20for%20OTC%20Human%20Use%2004.04.22.pdf. Date Accessed October 7, 2026.
Other Therapies: Diarrhoea and Vomiting Caused by Gastroenteritis. https://www.ncbi.nlm.nih.gov/books/NBK63850/. Date Accessed October 7, 2026.