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 years 25 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 Type HUMAN OTC DRUG Item Code (Source) NDC:54838-116
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 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid (UNII: XF417D3PSL)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
sodium citrate (UNII: 1Q73Q2JULR)  
water (UNII: 059QF0KO0R)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Product Characteristics
Color      Score     
Shape Size
Flavor LEMON (Lemon Vanilla Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-116-80 473 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 10/05/1990
Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 6/2014
Document Id: a17022ea-3918-485f-a68c-1c5549a9bb52
Set id: 38733915-c3a8-4e44-8453-5d4bd592f3f8
Version: 13
Effective Time: 20140625
 
Silarx Pharmaceuticals, Inc