Lubricant Laxatives

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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.

Medicinal Ingredients

• Mineral Oil (Heavy)

Lubricant Action: An agent that lubricates the contents of the intestinal tract, thereby promoting bowel movement.

Usual Claims:

• lubricant laxative
• for relief of occasional constipation

Warnings: As for all classes.

Directions:

1. Oral dosage form produces results in 6 to 8 hours.
2. Rectal dosage form produces results in 2 to 15 minutes.
3. Commonly administered at bedtime.

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: Children under 6 years - consult physician

Ingredients	Adult to 12 years	Maximum	Children 6 to 12 years
Mineral Oil (Oral)	15 ml	45 ml	5 to 15 ml
Children under 2 years - consult physician
Ingredients	Adult to 12 years	Maximum	Children 2 to 12 years
Mineral Oil (Rectal)	120 ml	single dose	60 ml