Your browser does not support JavaScript! SILACE (DOCUSATE SODIUM) LIQUID [SILARX PHARMACEUTICALS, INC]
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RxNorm Names

SILACE (docusate sodium) liquid
[Silarx Pharmaceuticals, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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

Purpose: Stool Softener

Uses

  • for gentle, reliable relief from occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warning

  • Do not use laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil unless told to do by a doctor

Ask doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that last over two weeks

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

  • take as indicated by doctor
  • this product must be given in a 6 to 8 oz. glass of milk or fruit juice or infant's formula to prevent throat irritation. Dose may be taken as a single daily dose or in divided doses
  • dosage should be adjusted to individual response
  • higher doses are recommended for initial therapy
  • the effect on stools is usually apparent 1 to 3 days after the first dose

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

  • store at room temperature 20°-25°C (68°-77°F)
  • protect from freezing and excessive heat
  • do not use if tamperevident safety seal around cap is broken or missing
  • dispense in tight, light-resistant container with a child-resistant closure

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 (161630033)

Revised: 6/2014
 
Silarx Pharmaceuticals, Inc

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