Label: STOOL SOFTENER- docusate sodium capsule, liquid filled

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

Drug Label Information

Updated March 18, 2024

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  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

  • Purpose

    Stool softener laxative

  • Uses

    • for temporary 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 care professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (188-222-1222) 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?

    Call toll free 1-866-4-REXALL

  • Principal Display Panel

    Stool Softener

    Docusate Sodium 100 mg

    Stool softener laxative

    • Stimulant-free

    Softgels

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

    DISTRIBUTED BY

    OLD EAST MAIN CO.

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

  • Product Label

    Docusate Sodium USP, 100 mg

    REXALL Stool Softener

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-939(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)  
    SORBITAN (UNII: 6O92ICV9RU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULE (Oval) Size13mm
    FlavorImprint Code PC1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-939-20200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/15/2022
    Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
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