Otc - Active Ingredient
Active Ingredient: Docusate sodium 10 mg (in each 1 mL)
Silace
FDA Label NDC 17856-0116
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Silace (NDC 17856-0116). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, warning, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Stool Softener
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
Otc - Ask Doctor
Ask doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that last over two weeks
Otc - Stop Use
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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.
Otc - Questions
Questions
888-974-5279
This product is not manufactured or distributed by Purdue Products LP, distributor of Colace® Liquid.
Manufactured by:
Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave
Carmel, NY 10512
USA
* Please review the disclaimer below.
