Label: DOCUSATE SODIUM capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2023

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) 
    • generally produces bowel movement in 12 to 72 hours
  • Warnings

    Do not use if you are presently taking mineral oil, unless directed by a doctor

    Ask a doctor before use if you have

    • stomach pain
    • nausea or 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 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. (1-800-222-1222)

  • 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 1-3 softgels daily
    children 2 to under 12 years of agetake 1 softgel daily
    children under 2 years of ageask a doctor

  • Other information

    • Tamper Evident: Do not use if seal is broken or missing from bottle
    • each softgel contains: sodium 6 mg
    • VERY LOW SODIUM
    • store at 25 oC (77 oF); excursions permitted between 15 o-30 oC (59 o-86 oF).

    keep tightly closed.

  • Inactive ingredients

    D&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 Mon-Fri 8 AM to 4 PM

  • PRINCIPAL DISPLAY PANEL

    Docusate

    Sodium

    image

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55289-493(NDC:16103-399)
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    Colorred (Two-toned- white and clear red) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SCU2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55289-493-1212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/21/2021
    2NDC:55289-493-1414 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
    3NDC:55289-493-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
    4NDC:55289-493-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
    5NDC:55289-493-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2018
    6NDC:55289-493-93180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/28/2023
    7NDC:55289-493-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/01/2016
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(55289-493)