Label: SILACE- docusate sodium syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated June 14, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient: Docusate sodium 60 mg (in each 15 mL (1 tablespoonful))

  • PURPOSE

    Purpose: Stool Softener

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    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 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION


    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
  • STORAGE AND HANDLING

    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 INGREDIENT

    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

    Questions

    888-974-5279


  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Silarx Pharmaceutical, Inc.

    19 West Street

    Spring Valley , NY 10977-USA.



    Relabeling of additional barcode by:
    Physicians Total Care, Inc.
    Tulsa, OK       74146

  • PRINCIPAL DISPLAY PANEL

    SILACE (docusate sodium) syrup

    473 mL (1 Pint)

    NDC 54868-6311-0

    image of package label

  • INGREDIENTS AND APPEARANCE
    SILACE 
    docusate sodium syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6311(NDC:54838-107)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Docusate sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate sodium60 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    alcohol (UNII: 3K9958V90M)  
    citric acid (UNII: 2968PHW8QP)  
    D&C red no. 33 (UNII: 9DBA0SBB0L)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINT (peppermint Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-6311-0473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/22/2011
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel, repack
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