Laxative Products

Over-the-counter (OTC) laxative monographs are guidelines established by the U.S. Food and Drug Administration (FDA) to ensure the safety and effectiveness of laxatives available without a prescription. These monographs outline different types of laxatives, such as bulk-forming, stimulant, stool softener, and saline laxatives. They specify ingredients, dosage amounts, and labeling requirements to help consumers choose the right laxative for occasional constipation. The FDA also reviews and updates these monographs to reflect new scientific information and ensure consumer safety.

M007.10 Bulk-forming laxative active ingredients

Active Ingredients OTC Monograph Number
BranM007.10 (Part 334)
Cellulose (semisynthetic) ingredients
  • Methylcellulose
  • Sodium carboxymethylcellulose
M007.10 (Part 334)
KarayaM007.10 (Part 334)
Malt soup extractM007.10 (Part 334)
PolycarbophilM007.10 (Part 334)
Psyllium ingredients except those (in granular dosage form) listed in Non-Monograph Conditions NM900. 2
  • Plantago ovata husks
  • Plantago seed
  • Psyllium (hemicellulose)
  • Psyllium hydrophilic mucilloid
  • Psyllium seed
  • Psyllium seed (blond)
  • Psyllium seed husks
M007.10 (Part 334)

M007.12 Hyperosmotic laxative active ingredients

Active Ingredients OTC Monograph Number
GlycerinM007.12 (Part 334)
SorbitolM007.12 (Part 334)

M007.14 Lubricant laxative active ingredients

Active Ingredients OTC Monograph Number
Mineral oil when used within the dosage limit establishedM007.14 (Part 334)

M007.16 Saline laxative active ingredients

Active Ingredients OTC Monograph Number
Magnesium citrateM007.16 (Part 334)
Magnesium hydroxideM007.16 (Part 334)
Magnesium sulfateM007.16 (Part 334)
Dibasic sodium phosphate/monobasic sodium phosphate marketed as a solutionM007.16 (Part 334)
Dibasic sodium phosphateM007.16 (Part 334)
Monobasic sodium phosphateM007.16 (Part 334)

M007.18 Stimulant laxative active ingredients

Active Ingredients OTC Monograph Number
Castor oilM007.18 (Part 334)
Dehydrocholic acidM007.18 (Part 334)

M007.20 Stool softener laxative active ingredients

Active Ingredients OTC Monograph Number
Docusate calciumM007.20 (Part 334)
Docusate potassiumM007.20 (Part 334)
Docusate sodiumM007.20 (Part 334)

M007.22 Carbon-dioxide-releasing laxatives

Active Ingredients OTC Monograph Number
Carbon dioxide released from combined sodium biphosphate anhydrous, sodium acid pyrophosphate, and sodium bicarbonateM007.22 (Part 334)
Carbon dioxide released from combined sodium bicarbonate and potassium bitartrateM007.22 (Part 334)

These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.

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