Label: STOOL SOFTENER DOCUSATE SODIUM 50 MG- docusate sodium capsule, liquid filled

  • NDC Code(s): 51013-111-20, 51013-111-24
  • Packager: PuraCap Pharmaceutical LLC
  • Category: HUMAN OTC DRUG LABEL

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 December 10, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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 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 could be signs of a serious condition.
    • you need to use a stool softener laxative for more than 1 week

    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 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 15°-30°C (59°-86°F)

      Keep tightly closed.

  • Inactive ingredients

    citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

    Manufactured by:
    Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
    Wuhan, Hubei 430206,
    China

  • PRINCIPAL DISPLAY PANEL - 30ct

    STOOL SOFTENERNDC 51013-111-20

    Compare to the active ingredient in Colace® 50 mg

    50 MG DOCUSATE SODIUM PER SOFTGEL 30 Softgels

    Carton Label

    Bottle Label

  • PRINCIPAL DISPLAY PANEL - 100ct

    STOOL SOFTENER NDC 51013-111-24

    Compare to the active ingredient in Colace® 50 mg

    50 MG DOCUSATE SODIUM PER SOFTGEL 100 Softgels

    Carton Label

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER DOCUSATE SODIUM 50 MG 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-111
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Colorred (clear) Scoreno score
    ShapeCAPSULE (OVAL) Size13mm
    FlavorImprint Code PC20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51013-111-201 in 1 CARTON08/22/2014
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:51013-111-241 in 1 CARTON08/22/2014
    2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/22/2014
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287analysis(51013-111) , manufacture(51013-111)
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

More Info on this Drug

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