Label: STOOL SOFTENER- docusate sodium capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 15, 2024

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  • Active ingredient (in each softgel)

    Docusate sodium USP,  100 mg

  • Purpose

    Stool softener laxative

  • Uses

    • for relief of occasional constipation and irregularity 
    • this product generally produces bowel movement in 12 to 72 hours
  • Warnings

    Do not use

    if you are presently taking mineral oil, unless directed by a doctor.

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • a sudden change in bowel habits that lasts more than 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding or no bowel movement after using a laxative. These could be sign 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.

  • Directions

    • take with a glass of water
     adults and children 12 years and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
     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 7 mg
    • store at 25ºC (77º); excursions permitted between 15-30ºC (59º-86ºF)
  • Inactive ingredients

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

  • Questions or comments?

    Call1-888-309-9030

  • Principal Display Panel

    Compare to active ingredient in Dulcolax® Stool Softener**

    Gentle Relief

    Stool Softener

    Docusate Sodium, 100 mg

    Stool softener laxative

    Fast, Dependable Relief of Occasional Constipation

    100 mg

    Softgels

    **This product is not manufactured by Chattem, Inc., distributor of Dulcolax® Stool Softener.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY

    OLD EAST MAIN CO.

    100 MISSION RIDGE

    GOODLETTSVILLE, TN  37072

  • Product Label

    Docusate Sodium 100mg Single Tone Softgels DG PUR

    DOLLAR GENERAL Docusate Sodium 100 mg softgels

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-938(NDC:53345-008)
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULE (Oval) Size13mm
    FlavorImprint Code PC1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-938-501 in 1 BOX12/30/2022
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:55910-938-251 in 1 BOX12/30/2022
    225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/30/2022
    Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
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