SILACE - docusate sodium syrup 
Silarx Pharmaceuticals,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.


Silace syrup

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

Purpose: Stool Softener



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.


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.



Manufactured by:

Silarx Pharmaceutical, Inc.

1033 Stoneleigh Ave

Carmel , NY 10512-USA.

Container label

docusate sodium syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54838-107
Route of Administration ORAL DEA Schedule     
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)  
anhydrous citric acid (UNII: XF417D3PSL)  
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
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-107-80 473 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 03/05/1990
Labeler - Silarx Pharmaceuticals,Inc (161630033)

Revised: 6/2014
Document Id: f422390a-1793-4e38-a43b-1163205f2a47
Set id: 5bd29e4d-ea87-4436-9dc9-624c7f7c1561
Version: 14
Effective Time: 20140625
Silarx Pharmaceuticals,Inc