Label: CVS HEALTH STOOL SOFTENER CLEAR- 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 18, 2022

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Docusate sodium 100 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 3 softgels
    daily
     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 5 mg 

    ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). 

    ■ Keep tightly closed

  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol-400, povidone (PVP K-30), propylene glycol, purified water, sorbitol solution, titanium dioxide

  • QUESTIONS

    Questions or comments? 1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    CVS Health

    Compare to the
    active ingredient
    in Colace®*

    Stool
    Softener
    DOCUSATE SODIUM, 100 mg
    •Relieves constipation

    • Stimulant free
    • Gentle & effective

    DYE
    FREE

    60 SOFTGELS

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

    image description

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH STOOL SOFTENER CLEAR 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-633
    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
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    Colorwhite (natural color) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 100
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-633-601 in 1 CARTON02/11/2020
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/11/2020
    Labeler - CVS Pharmacy (062312574)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!