Label: CVS HEALTH STOOL SOFTENER- docusate sodium capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 30, 2021

If you are a consumer or patient please visit this version.

  • 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 not finalpart33406/05/2019
    Labeler - CVS Pharmacy (062312574)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LTD677385498manufacture(69842-523)