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.
I Medicinal Ingredients
- Cascara Sagrada ingredients
- Cascara fluid extract, aromatic
- Cascara Sagrada bark
- Cascara Sagrada extract
- Cascara Sagrada fluid extract
- Castor Oil
- Dehydrocholic Acid
- Bile Salts
- Sennosides A and B
- Senna leaf powder
- Senna fluid extract
- Senna fruit extract
- Senna syrup
- Senna pod concentrate
- Sennosides A and B crystalline
II Stimulant Action
Promotes bowel movement by direct action on the intestine.
III Usual Claims
- stimulant laxative
- relief of occasional constipation
As for all classes.
- Oral products produce action in 6 to 12 hours.
- Rectal products produce action in 1/4 to 1 hour.
- Do not chew tablets or take with milk or antacid (bisacodyl enteric-coated tablets only).
- Do not take late in day, results within 2 to 6 hours (Castor oil only) (O.K. if reflected in directions for use).
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.
- Children under 2 years - consult physician (for DIN's).
- Children under 6 years - consult physician (for GP's)
|Ingredients||Adult to 12 years||Maximum||Children 6 to 12 years||Children less than 6 years|
|Aloes||120 to 250 mg||single dose||80 to 120 mg||consult physician|
|- Oral||5 to 15 mg||single dose||5 mg||consult physician|
|- Rectal||10 mg||single dose||5 mg||consult physician|
|a. Casanthranol||30 to 90 mg||single dose||15 to 45 mg||15 to 45 mg|
|b. Cascara Fluid Extract Aromatic||2 to 6 ml||single dose||1 to 5 ml||1 to 5 ml|
|c. Cascara Sagrada Bark||300 to 1000 mg||single dose||150 to 500 mg||150 to 500 mg|
|d. Cascara Sagrada Extract||200 to 400 mg||single dose||100 to 200 mg||100 to 200 mg|
|e. Cascara Sagrada Fluid Extract||0.5 to 1.5 ml||single dose||.25 to .75 ml||.25 to .75 ml|
|Castor Oil||15 to 50 ml||single dose||5 to 15 ml||5 to 15 ml|
|Dehydrocholic Acid||250 to 500 mg 3 times daily p.c.||150 mg in 24 hours||consult physician||consult physician|
|Sennosides A & B|
|- Oral||12 to 50 mg||once or twice daily|
|- Rectal||30 mg||once or twice daily|
|Senna Leaves||0.5 to 2 gm||once daily||consult physician||consult physician|
|Senna Fluid Extract 1:1||2 ml||once daily||consult physician||consult physician|
|Preparing for Colon X-Ray (Oral)||160 mg||single dose||consult physician||consult physician|
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