Label: STOOL SOFTENER- docusate sodium capsule, liquid filled 

  • NDC Code(s): 15127-288-10
  • Packager: Stephen L. LaFrance Pharmacy, Inc.
  • 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 10/13

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

  • Active ingredient (in each liquid gel)

    Docusate sodium 100 mg

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  • Purpose

    Stool softener laxative 

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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

    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 

    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 (1-800-222-1222) right away. 

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  • Directions

    • take only by mouith.  Doses may be taken as a single daily dose or in divided doses.
    • take with a glass of water
    adults and children
    12 years and over 

    take 1 to 3 liquid gels
    daily 

    children 2 to under
    12 years of age
    take 1 liquid gel daily 
    children under
    2 years of age
    ask a doctor 
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from excessive humidity
    • use by expiration date on package 
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  • Inactive ingredients

    D&C yellow #10, edible white ink, FD&C red #40, gelatin, glycerine, polyethylene glycol, propylene glycol, sorbitol 

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  • Questions or comments?

    1-800-426-9391

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  • Principal display panel

    select brand®
    the lower name brand

    NDC 15127-288-10

    Stool Softender
    Docuate sodium100 mg
    Gentle
    Effective
    Stimulant Free
    for comfortable relief

    *Compare to the active ingredient in Colace®

    250 Liquid Gels 

    *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.
    50844    REV0211D35112

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

    Select Brand 44-351

    Select Brand 44-351

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  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:15127-288
    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
    D&C YELLOW NO. 10  
    FD&C RED NO. 40  
    GLYCERIN  
    GELATIN  
    PROPYLENE GLYCOL  
    SORBITOL  
    Product Characteristics
    Color RED Score no score
    Shape CAPSULE Size 13mm
    Flavor Imprint Code A92
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:15127-288-10 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 09/21/1995
    Labeler - Stephen L. LaFrance Pharmacy, Inc. (043562370)
    Establishment
    Name Address ID/FEI Business Operations
    Accucaps Industries, Ltd. 248441727 MANUFACTURE(15127-288)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(15127-288)
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