FDA Label for Silace
View Indications, Usage & Precautions
Silace Product Label
The following document was submitted to the FDA by the labeler of this product Lannett Company, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Uses
- for gentle, reliable relief from occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Warning
- Do not use laxative products for longer than 1 week unless told to do so by a doctor
- if you are presently taking mineral oil unless told to do by a doctor
Directions
- take as indicated by doctor
- this product must be given in a 6 to 8 oz. glass of milk or fruit juice or infant's formula to prevent throat irritation. Dose may be taken as a single daily dose or in divided doses
- dosage should be adjusted to individual response
- higher doses are recommended for initial therapy
- the effect on stools is usually apparent 1 to 3 days after the first dose
Adults and children over 12 years | 50 to 200 mg (1 to 4 teaspoonful) |
Children 6 to under 12 years | 50 to 100 mg (1 to 2 teaspoonful) |
Children 3 to under 6 years | 25 to 50 mg(1/2 to 1 teaspoonful) |
Children under 3 years of age | Ask a doctor |
Other Information
- store at room temperature 20°-25°C (68°-77°F)
- protect from freezing and excessive heat
- do not use if tamperevident safety seal around cap is broken or missing
- dispense in tight, light-resistant container with a child-resistant closure
Inactive Ingredients
citric acid, D&C red no. 33, flavor, methylparaben, Poloxamer, propylene glycol, propylparaben, purified water, sodium citrate.
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