Label: STOOL SOFTENER- docusate sodium and sennosides capsule, gelatin coated

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

Drug Label Information

Updated December 6, 2023

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

  • PURPOSE

    Active ingredients (in each softgel)Purpose
    Docusate sodium 50 mg  Stool softener
     Sennosides 8.6 mg Stimulant Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 6-12 hours
  • WARNINGS

    Warnings

    Do not use

    • laxative products for longer than 1 week unless told to do so by a doctor
    • 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 may indicate a serious condition.

    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 right away.

  • Directions

    • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
     adults and children 12 years of age or over take 2-4 softgels daily
     children 6 to under 12 years of age       take 1-2 softgels daily
     children 2 to under 6 years of age    take upto 1 softgel daily
     children under 2 ask a doctor

  • Other information

    • each softgel contains: calcium 2 mg and sodium 3 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • Keep tightly closed
  • Inactive ingredients

    Aerosil, beeswax, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide

  • Questions?

    Call 1-888-333-9792 Monday-Friday 9AM-5PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL

    ♥CVSHealth™

    Compare to the
    active ingredients in
    COLACE® 2-IN-1*

    Liquid Filled Softgels

    NDC 69842-319-60

    Stool Softener
    DOCUSATE SODIUM, 50 mg
    SENNOSIDES, 8.6 mg
    Plus stimulant laxative

    Package Contains One Bottle

    60 SOFTGELS

    Actual Size

    *This product is not manufactured or distributed by Purdue Products L.P., owner of the
    registered trademark COLACE® 2-IN-1.

    image description

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium and sennosides capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-319
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred (OPAQUE) Scoreno score
    ShapeCAPSULE (SOFTGEL) Size12mm
    FlavorImprint Code 584
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-319-601 in 1 CARTON03/15/2018
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/15/2018
    Labeler - CVS (062312574)
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