Lubricant Laxatives
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:
- Oral dosage form produces results in 6 to 8 hours.
- Rectal dosage form produces results in 2 to 15 minutes.
- 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.
| 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 |