Label: DOCUSATE SODIUM capsule

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 2, 2023

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

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool softener laxative

  • Uses

    • for relief of occasional constipation (irregularity)
    • this product 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 last 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 a signs of a serious condition.
    • 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 (1-800-222-1222)  right away.

  • Directions

    • take with a glass of water
    adults and children 12 years and overtake 1 to 3 softgels daily.
    children 2 to under 12 years of agetake 1 softgel daily
    children under 2 years ask a doctor
  • Other information

    • each softgel contains: sodium 5 mg
    • store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)
  • Inactive ingredients

    edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • HOW SUPPLIED

    For identification purposes, each orange softgel will have an imprint that reads P51.

    NDC 72789-295-30 Bottles of 30 softgels.

    NDC 72789-295-90 Bottles of 90 softgels.

  • Principal Display Panel

    Docusate Sodium

    Stool Softener Laxative

    TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLR.

  • Product Label

    72789295 Label
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72789-295(NDC:50804-862)
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITAN (UNII: 6O92ICV9RU)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code P51
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72789-295-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/23/2022
    2NDC:72789-295-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/23/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/28/2021
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(72789-295)