SILACE - docusate sodium syrup 
Physicians Total Care, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Silace syrup

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

Purpose: Stool Softener

Uses


Warnings

Ask a doctor before use if you have


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

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Directions


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

Other information

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

888-974-5279


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

SILACE (docusate sodium) syrup

473 mL (1 Pint)

NDC 54868-6311-0

image of package label

SILACE 
docusate sodium syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6311(NDC:54838-107)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate sodium60 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorPEPPERMINT (peppermint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-6311-0473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/22/2011
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel, repack

Revised: 6/2011
Document Id: 58971aed-8e11-476b-b52f-d0f60a37532a
Set id: 138f601b-698e-4cf1-88d0-c34d5d2c9299
Version: 1
Effective Time: 20110614
 
Physicians Total Care, Inc.