Label: STOOL SOFTENER- docusate sodium capsule, liquid filled 

  • NDC Code(s): 55301-351-12
  • Packager: ARMY AND AIR FORCE EXCHANGE SERVICE
  • 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 07/13

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

    exchange select™

    STOOL SOFTENER
    Docusate sodium 100 mg

    Compare To The Active Ingredient of Colace®*

    • Gentle
    • Effective
    • Stimulant-Free
    For Comfortable Relief

    100 LIQUID GELS

    *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.
    Product of Canada        50844    REV0712D35112

    SATISFACTION GUARANTEED OR YOUR MONEY BACK 
    Manufactured For: Your Military Exchanges
    Distributed by: LNK International, Inc., Hauppauge, NY 11788

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

    Exchange Select 44-351

    Exchange Select 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:55301-351
    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:55301-351-12 100 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 - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
    Establishment
    Name Address ID/FEI Business Operations
    Accucaps Industries, Ltd. 248441727 MANUFACTURE(55301-351)
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