SILACE - docusate sodium liquid 
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 Liquid

Active Ingredient: Docusate sodium 10 mg (in each 1 mL)

Purpose: Stool Softener

Uses

Warning

Ask 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 over 12 years
50 to 200 mg (1 to 4 teaspoonful)
Children 6 to under 12 years
50 to 100 mg (1 to 2 teaspoonful)
Children 3 to under 6 years25 to 50 mg(1/2 to 1 teaspoonful)
Children under 3 years of age
Ask a doctor

Other information

Inactive ingredients

citric acid, D&C red no. 33, flavor, methylparaben, Poloxamer, propylene glycol, propylparaben, purified water, sodium citrate.

Questions

888-974-5279

This product is not manufactured or distributed by Purdue Products LP, distributor of Colace® Liquid.

Manufactured by:

Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave
Carmel, NY 10512
USA

Container Label

SILACE 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54838-116
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate sodium (Docusate) Docusate sodium10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
D&C red no. 33 
methylparaben 
propylene glycol 
propylparaben 
sodium citrate 
water 
Poloxamer 407 
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (Lemon Vanilla Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54838-116-80473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/05/1990
Labeler - Silarx Pharmaceuticals, Inc (078500185)

Revised: 12/2013
Document Id: 8aecbe31-ecc5-4759-b7c2-b1c2641f436e
Set id: 38733915-c3a8-4e44-8453-5d4bd592f3f8
Version: 12
Effective Time: 20131203
 
Silarx Pharmaceuticals, Inc