Label: EXTRA STRENGTH STOOL SOFTENER LAXATIVE- 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 October 10, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient (in each softgel)

    Docusate Sodium 250 mg

  • PURPOSE

    Purpose

    Stool Softener

  • INDICATIONS & USAGE

    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 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. These could be signs of a serious condition.

  • PREGNANCY OR BREAST FEEDING

    •ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

  • INFORMATION FOR PATIENTS

    Directions:

    Adults and children 12 years of age and over:

    take 1 softgel daily or as directed by a doctor.

    Children under 12 years of age: take as directed by doctor.

    Other Information:

    each softgel contains: sodium 15 mg.

    Store between 15-30 C (59-86 F)

  • INACTIVE INGREDIENT

    edible white ink, FD&C red 40, FD&C yellow 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

  • PRINCIPAL DISPLAY PANEL

    UD Blister

    Box Label

  • DOSAGE & ADMINISTRATION

  • KEEP OUT OF REACH OF CHILDREN

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH STOOL SOFTENER LAXATIVE 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52327-011(NDC:0536-3757)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg  in 250 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
    ShapeOVALSize20mm
    FlavorImprint Code P20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52327-011-11100 in 1 BLISTER PACK10/20/2014
    1NDC:52327-011-101 mg in 1 BLISTER PACK
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/20/2014
    Labeler - Aidapak Services, LLC (831612457)
    Registrant - Aidapak Services, LLC (831612457)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidapak Services, LLC831612457relabel(52327-011)
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