Label: DOCQLACE- docusate sodium capsule

  • 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 September 10, 2013

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  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

  • Purpose

    Stool softener

  • Uses

    • relieves occasional constipation (irregularity)  
    • generally produces bowel movement in 12 to 72 hours
  • Warnings

  • DO NOT USE

    Do not use if you are presently taking mineral oil, unless told to do so by a doctor

  • Ask a doctor before use if you have

    • stomach pain  
    • nausea  
    • vomiting  
    • noticed a sudden change in bowel habits that lasts over 2 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.  
    • you need to use a laxative for more than 1 week
  • PREGNANCY OR BREAST FEEDING

    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

    doses may be taken as a single daily dose or in divided doses

    adults and children 12 years and over take 1-3 softgels daily 
    children 2 to under 12 years of age take 1 softgel daily 
    children under 2 years ask a doctor 
  • Other information

    • each softgel contains: sodium 5 mg VERY LOW SODIUM  
    • store at 15°-30°C (59°-86°F)  
    • keep tightly closed

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

  • Inactive ingredients

    FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    QUALITEST PHARMACEUTICALS
    HUNTSVILLE, AL 35811

    They are supplied by State of Florida DOH Central Pharmacy as follows:

    NDCStrengthQuantity/FormColorSource Prod. Code
    53808-0677-1100 mg30 Capsules in a Blister PackReddish0603-0150
  • PRINCIPAL DISPLAY PANEL

    This is an image of the label for DocQLace 30 count softgels. 

  • INGREDIENTS AND APPEARANCE
    DOCQLACE 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-0677(NDC:0603-0150)
    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 GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorRED (Reddish) Scoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53808-0677-130 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33401/01/2013
    Labeler - State of Florida DOH Central Pharmacy (829348114)
    Establishment
    NameAddressID/FEIBusiness Operations
    State of Florida DOH Central Pharmacy829348114repack(53808-0677)
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