SILACE  - docusate sodium liquid 
Silarx Pharmaceuticals, Inc

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Silace Liquid

Drug Facts

Active ingredient (in each 1 mL)                                     Purpose

Docusate sodium 10 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 (5-20 mL)
Children 6 to under 12 years
40 to 120 mg (4-12 mL)
Children 3 to under 6 years 20 to 60 mg(2-6 mL)
Infants and children under 3 years
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.
19 West Street
Spring Valley, NY 10977
USA

Container Label


SILACE 
docusate sodium   liquid
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 54838-116
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Docusate sodium (Docusate) Docusate sodium 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid  
D&C red no. 33  
methylparaben  
propylene glycol  
propylparaben  
sodium citrate  
water  
Poloxamer 407  
Product Characteristics
Color      Score     
Shape Size
Flavor LEMON (Lemon Vanilla Flavor) Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 54838-116-80 473 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/05/1990

Labeler - Silarx Pharmaceuticals, Inc (161630033)
Revised: 06/2010 Silarx Pharmaceuticals, Inc