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 Physicians Total Care, 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.
Otc - Active Ingredient
Active Ingredient: Docusate sodium 60 mg (in each 15 mL (1 tablespoonful))
Otc - Purpose
Purpose: Stool Softener
Indications & Usage
Uses
- for gentle, reliable relief from occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Warnings
Warnings
- Do not use
- laxative products for longer than 1 week unless told to do so by a doctor
- Do not use if you are presently taking mineral oil unless told to do by a doctor
Otc - Ask Doctor
Ask a 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.
Dosage & Administration
Directions
- take as directed by a doctor
- doses must be given in a 6-8 oz glass of milk or fruit juice, to prevent throat irritation
- dose may be taken as a single daily dose or in divided doses
- dosage should be adjusted to individual response
| Adults and children 12 years of age and older | 1 to 6 tablespoonfuls, or as directed by a doctor |
| Children 6 to under 12 years of age | 1 to 2 1/2 tablespoonfuls, or as directed by a doctor |
| Children under 6 years | Ask a doctor |
Storage And Handling
Other information
- store at room temperature 20°-25°C (68°-77°F)
- protect from freezing and excessive heat
- do not use if tamper-evident safety seal around cap is broken or missing
- dispense in tight, light-resistant container with a child-resistant closure
Inactive Ingredient
Inactive ingredients:
alcohol not more than 1%, citric acid, D&C red no. 33, FD&C red no. 40, peppermint flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucrose.
Otc - Questions
Questions
888-974-5279
Other
Manufactured by:
Silarx Pharmaceutical, Inc.
19 West Street
Spring Valley , NY 10977-USA.
Relabeling of additional barcode by:
Physicians Total Care, Inc.
Tulsa, OK 74146
Package Label.Principal Display Panel
SILACE (docusate sodium) syrup
473 mL (1 Pint)
NDC 54868-6311-0
* Please review the disclaimer below.