Label: CVS HEALTH STOOL SOFTENER- docusate sodium capsule

  • 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 (in each softgel)

    Docusate sodium 50 mg

  • Purpose

    Stool softener

  • Uses

    ■ relieves occasional constipation (irregularity)
    ■ generally produces bowel movement in 12 to 72 hours

  • Warnings

    Do not use
    ■ if you are presently taking mineral oil, unless told to do
    so by a doctor

  • ASK DOCTOR/PHARMACIST

    Ask a doctor before use if you have
    ■ stomach pain ■ nausea ■ vomiting
    ■ noticed a sudden change in bowel habits that lasts over
    2 weeks

  • DO NOT USE

    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 stool softener laxative for more than
    1 week

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional
    before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get
    medical help or contact a Poison Control Center right
    away. 1-800-222-1222

  • Directions

    Take only by mouth. Doses may be taken as a single daily
    dose or in divided doses.

     adults and children 12 years
    and over     		 take 1 to 6 softgels
    daily
     children 2 to under 12 years
    of age     		 take 1 to 3 softgels
    daily
     children under 2 years ask a doctor

  • Other information

    ■ each softgel contains: sodium 3 mg VERY LOW
    SODIUM
    ■ store at 25°C (77°F); excursions permitted between
    15°-30°C (59°-86°F). Keep tightly closed.

  • Inactive ingredients

    FD&C Red No. 40, gelatin, glycerin, polyethylene
    glycol-400, povidone, propylene glycol, purified water,
    sorbitol solution, titanium dioxide

  • QUESTIONS

    Questions or comments? 1-888-333-9792

  • WARNINGS

  • PRINCIPAL DISPLAY PANEL

    CVS Health

    Compare to the
    active ingredient
    in Colace

    Stool
    Softener
    DOCUSATE SODIUM, 50 mg
    • Stimulant free
    • Gentle & effective
    • Comfortable relief
    of constipation

    Actual Bottle Size
    on Side Pane

    100 SOFTGELS

    RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

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

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

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2019 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    Made in India V-33609

    image description

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH STOOL SOFTENER 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-523
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code S10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-523-011 in 1 CARTON06/05/2019
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00706/05/2019
    Labeler - CVS Pharmacy (062312574)
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