SILACE - docusate sodium liquid 
Carilion Materials Management

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

HOW SUPPLIED

Product: 68151-0116

NDC: 68151-0116-1 1 mL in a CUP, UNIT-DOSE

SILACE (DOCUSATE SODIUM) LIQUID

Label Image
SILACE 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68151-0116(NDC:54838-116)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
water (UNII: 059QF0KO0R)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (Lemon Vanilla Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68151-0116-11 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product12/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/05/1990
Labeler - Carilion Materials Management (079239644)
Establishment
NameAddressID/FEIBusiness Operations
Carilion Materials Management079239644REPACK(68151-0116)

Revised: 12/2017
Document Id: 974b3e52-3710-498b-8d59-d96491d23b9c
Set id: 6e995a27-e841-4c7f-bcb1-b2f5ef25d9e6
Version: 2
Effective Time: 20171228
 
Carilion Materials Management