Label: DOCUSATE SODIUM 50MG SOFTGEL (RED)- docusate sodium capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 4, 2025

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each softgel)

    Docusate sodium USP 50 mg

  • PURPOSE

    Purpose

    Stool softener

  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours

  • WARNINGS

    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 lasts 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 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).

  • DOSAGE & ADMINISTRATION

    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 1-6 softgels daily

    children 2 to

    under 12 years of age     		take 1-3 softgels daily
    children under 2 years ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • each softgel contains: sodium 3 mg VERY LOW SODIUM
    • Keep tightly closed. Store at 25°C (77°F); excursions permitted between 15°-30°C (59-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients D&C red 33, FD&C blue 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac, titanium dioxide

  • QUESTIONS

    Questions or comments? Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    651T_100ct_IFC

    651T_100ct_LBL

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 50MG SOFTGEL (RED) 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-651
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SHELLAC (UNII: 46N107B71O)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code 164
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-651-011 in 1 CARTON03/06/2025
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/06/2025
    Labeler - CVS Pharmacy (062312574)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED925822975manufacture(51316-651)
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