Label: DOCUSATE SODIUM capsule, liquid filled

  • 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 May 14, 2015

If you are a consumer or patient please visit this version.

  • OTC - ACTIVE INGREDIENT SECTION

    Docusate Sodium 100 mg

  • OTC - PURPOSE SECTION

    Stool softener

  • INDICATIONS & USAGE SECTION

    • for prevention of dry, hard stools
    • for relief of occasional constipation

    This product generally produces a bowel movement within 12 to 72 hours.

  • WARNINGS SECTION

    Do not use

    • if you are currently taking mineral oil, unless directed by a doctor 
    • when abdominal pain, nausea, or vomiting are present
    • for longer than 1 week, unless directed by a doctor 

    Ask a doctor before use if

    if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have a bowel movement after use

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION SECTION

    Directions

     adults and children over 12 years of age take 1 to 3 softgels preferably at bedtime
     children 6-12 years of age take 1 softgel at bedtime
     children under 6 years ask a doctor

    Other information

    • each softgel contains: sodium 6 mg
    • store between 15º-30ºC (59º-86ºF)

    Questions or comments?

    1-800-645-2158

    Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN COLACE®*

    NON-HABIT FORMING

    Stool Softener Laxative

    Docusate Sodium USP, 100 mg

    SOFTGEL CAPSULES

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    *Rugby Laboratories is not affiliated with the owner of the trademark Colace®.

    Distributed by: Rugby Laboratories

    31778 Enterprise Drive

    Livonia, MI  48150

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

  • INACTIVE INGREDIENT SECTION

    edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-459(NDC:0536-3756)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code P51
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-459-71100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:61919-459-3030 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2014
    Labeler - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320relabel(61919-459)