Label: STOOL SOFTENER EXTRA STRENGTH- docusate sodium capsule, liquid filled

  • 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 9, 2012

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

View All Sections
  • Active ingredient (in each softgel)

    Docusate Sodium 250 mg

    Purpose

    Stool softener

  • Uses

    • for the prevention of dry, hard stools
    • for relief of occasional constipation.
    • this product generally produces a bowel movement within 12 to 72 hours.
  • Warnings - Do not use

    • if you are currently taking mineral oil, unless directed by a doctor
    • when abdominal pain, nausea, or vomiting are present
    • for more than 1 week, unless directed by a doctor

    Ask a doctor before use if

    you notice a sudden change in bowel habits that persists over a period of 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have a bowel movement after use

    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 1 softgel daily or as directed by a doctor adults and children over 12 years of age and over:
    • : take as directed by a doctor children under 12 years of age
  • Other information

    • sodium 15 mg each softgel contains:
    • store at controlled room temperature 15 - 30 C (59 - 86 F) oooo
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive Ingredients

    edible white ink, FD&C Red No# 40, FD&C Yellow No# 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

  • Questions or comments?

    Call toll free 1-877-753-3935

  • STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED

    Label Image
  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER   EXTRA STRENGTH
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0443(NDC:24385-443)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0443-11 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33407/09/2010
    Labeler - Atlantic Biologicals Corps (047437707)
    Registrant - Atlantic Biologicals Corps (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Biologicals Corps047437707RELABEL(17856-0443) , REPACK(17856-0443)
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!