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.

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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.

1033 Stoneleigh Ave

Carmel , NY 10512-USA.



Container label


SILACE 
docusate sodium syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54838-107
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate sodium (Docusate) Docusate sodium60 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
alcohol  
anhydrous citric acid 
D&C red no. 33 
FD&C red no. 40 
glycerin 
methylparaben 
propylene glycol 
propylparaben 
water 
sodium benzoate 
sodium citrate 
sucrose 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINT (peppermint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54838-107-80473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/05/1990
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