Label: DOCUSATE SODIUM capsule

  • NDC Code(s): 55289-493-14, 55289-493-30, 55289-493-60, 55289-493-90, view more
    55289-493-93
  • Packager: PD-Rx Pharmaceuticals, Inc.
  • 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 September 30, 2019

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

  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

  • Purpose

    Stool softener

  • Uses

    • relieves occasional constipation (irregularity)
    • results usually occurs 1 to 3 days after the first dose
  • Warnings


    Do not use

    Do not use if you are currently taking mineral oil, unless directed bya doctor

    Ask a doctor before use if you

    • stomach pain, nausea or vomiting
    • have noticed a sudden change in bowel habits that last over 2 weeks

    Stop use and ask a doctor if

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

    you need to use a stool softner 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

    • do not exceed recommended dose
    adults and children over 12 years and older                        
    take 1-3 softgels daily
    children 2 to 12 years of age
    take 1 softgel daily
    children under 2 years
    ask a doctor
  • Other information

    • Each capsule contains sodium 6mg
    • store at room temperature 15 o to 30 oC (59 o to 86 oF)
    • protect from moisture
  • Inactive ingredients: FD&C Red #33,Edible Ink,FD&C Red #40,FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol Special.


  • Questions?

    Adverse drug event call: (866) 562-2756

  • HOW SUPPLIED

    Supplied in bottles of 14, 30, 60, 90 and 180 softgels.

  • Principal Display Panel

    *Compare to the active ingredient of Colace®

    Docusate Sodium

    Stool Softener

    100 mg each

    image

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55289-493
    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
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorred (Two-toned- white and clear red) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SC02
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55289-493-1414 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
    2NDC:55289-493-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
    3NDC:55289-493-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
    4NDC:55289-493-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
    5NDC:55289-493-93180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/12/201801/31/2038
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(55289-493)