Laxatives: Stool Softener

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Contact: BGIVD Enquiries

Note: In the case of applications for drugs which fit the criteria of this labelling standard, it is not necessary to conduct an assessment to determine if bioequivalence, pharmacodynamic/clinical studies or pharmaceutical equivalence data must be submitted.

Active Ingredients:

Sulfosuccinate Preparations:

• Docusate Calcium
• Docusate Sodium
• Docusate Potassium

Stool Softeners Action: Stool Softeners act by penetrating and softening stools

Usual Claims:

• softens the stools
• laxative
• relief of occasional constipation
• gentle

Warnings: As for all classes.

Directions:

1. Drink increased fluids (one full glass or more).

Note: This labelling standard describes those requirements that are specific to this class of drugs. Other requirements described in the Regulations to the Food and Drugs Act and in the Guide for the Labelling of Drugs for Human Use should also be met.

Dosage

Ingredients	Adult	Maximum	Children 6 to 12 years	Children less than 6 years
Docusate Calcium Cap.	50 to 240 mg	480 mg	50 to 150 mg	consult physician
Docusate Potassium Cap.	100 to 300 mg	480 mg	100 mg	consult physician
Docusate Sodium Cap.	50 to 240 mg	500 mg	40 to 120 mg	consult physician
				Children 2 to 6 years
Docusate Sodium Solution	50 to 240 mg	500 mg	50 to 150 mg	10 to 50 mg
Docusate Sodium Syrup	50 to 240 mg	500 mg	50 to 150 mg	10 to 50 mg
Docusate Sodium Tablets	50 to 240 mg	500 mg	50 to 150 mg	10 to 50 mg

Children/Infants up to 2 years-as directed by a physician