SILACE- docusate sodium syrup

Silace by

Drug Labeling and Warnings

Silace by is a Otc medication manufactured, distributed, or labeled by Physicians Total Care, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Docusate sodium 60 mg (in each 15 mL (1 tablespoonful))

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
  

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
  

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding,

ask a health professional before use.

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.

QUESTIONS

Questions

888-974-5279

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

SILACE (docusate sodium) syrup

473 mL (1 Pint)

NDC: 54868-6311-0

INGREDIENTS AND APPEARANCE

SILACE 
docusate sodium syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54868-6311(NDC:54838-107)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Docusate sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG)	Docusate sodium	60 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
alcohol (UNII: 3K9958V90M)
citric acid (UNII: 2968PHW8QP)
D&C red no. 33 (UNII: 9DBA0SBB0L)
FD&C red no. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
sodium citrate (UNII: 1Q73Q2JULR)
sucrose (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT (peppermint Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54868-6311-0	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/22/2011

Labeler - Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Business Operations
Physicians Total Care, Inc.		194123980	relabel, repack