Label: DOCQLACE- docusate sodium capsule 

  • Label RSS
  • NDC Code(s): 0603-0150-21, 0603-0150-32
  • Packager: Qualitest Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

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  • Purpose

    Stool softener

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  • Uses

    • relieves occasional constipation (irregularity)  
    • generally produces bowel movement in 12 to 72 hours
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  • Warnings
  • DO NOT USE

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

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  • Ask a doctor before use if you have

    • stomach pain  
    • nausea  
    • vomiting  
    • noticed a sudden change in bowel habits that lasts over 2 weeks
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  • 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
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • Keep out of reach of children.

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

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  • 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 
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  • 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.

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  • Inactive ingredients

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

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    QUALITEST PHARMACEUTICALS
    HUNTSVILLE, AL 35811

    R0  07/2011
    015021CPR

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  • PRINCIPAL DISPLAY PANEL

    This is an image of the label for DocQLace 100 count softgels. 

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  • INGREDIENTS AND APPEARANCE
    DOCQLACE 
    docusate sodium capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0603-0150
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOL 400  
    WATER  
    SORBITOL  
    Product Characteristics
    Color RED (Reddish) Score no score
    Shape CAPSULE Size 12mm
    Flavor Imprint Code SCU1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-0150-21 100 in 1 BOTTLE, PLASTIC
    2 NDC:0603-0150-32 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 08/01/2011
    Labeler - Qualitest Pharmaceuticals (011103059)
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