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

SILACE (docusate sodium) syrup
[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 60 mg (in each 15 mL (1 tablespoonful))

Purpose: Stool Softener

Uses

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

Warnings

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

Ask a 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 directed by a doctor
  • doses must be given in a 6-8 oz glass of milk or fruit juice, to prevent throat irritation
  • dose may be taken as a single daily dose or in divided doses
  • dosage should be adjusted to individual response

Adults and children 12 years of age and older
1 to 6 tablespoonfuls, or as directed by a doctor
Children 6 to under 12 years of age
1 to 2 1/2 tablespoonfuls, or as directed by a doctor
Children under 6 years
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 tamper-evident safety seal around cap is broken or missing
  • dispense in tight, light-resistant container with a child-resistant closure

Inactive ingredients:

alcohol not more than 1%, citric acid, D&C red no. 33, FD&C red no. 40, peppermint flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucrose.

Questions

888-974-5279


Manufactured by:

Silarx Pharmaceutical, Inc.

1033 Stoneleigh Ave

Carmel , NY 10512-USA.



Container label


SILACE 
docusate sodium syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54838-107
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate sodium (Docusate) Docusate sodium60 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
alcohol  
anhydrous citric acid 
D&C red no. 33 
FD&C red no. 40 
glycerin 
methylparaben 
propylene glycol 
propylparaben 
water 
sodium benzoate 
sodium citrate 
sucrose 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINT (peppermint Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54838-107-80473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/05/1990
Labeler - Silarx Pharmaceuticals,Inc (161630033)

Revised: 6/2014
 
Silarx Pharmaceuticals,Inc

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