Label: STOOL SOFTENER- docusate sodium capsule, liquid filled

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

Drug Label Information

Updated April 4, 2024

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

View All Sections
  • Active ingredient (in each softgel)

    Docusate Sodium 250 mg

  • Purpose

    Stool Softener

  • Uses

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

    Ask a doctor before use if you

    • have stomach pain, nausea, or vomiting
    • have a sudden change in bowel habits that persists over a period of 2 weeks
    • are presently taking mineral oil

    Stop use and ask a doctor if

    • you need to use a laxative longer than 1 week
    • you have rectal bleeding or fail to have a bowel movement.

    These could be signs of a serious condition.

    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

    • adults and children 12 years and older: take 1 softgel daily or as directed by a doctor
    • children under 12: do not use
    • do not exceed recommended dose

  • Other information

    • each softgel contains: sodium 15 mg
    • store at 59°-77°F (15°-25°C)
    • keep tightly closed
    • product of Romania
    • Package not child resistant
    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • Inactive ingredients

    FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerol, PEG, purified water, sorbitol special

  • Questions or comments?

    1-800-540-3765

  • HOW SUPPLIED

    NDC: 71335-1677-1: 30 Capsules in a BOTTLE

    NDC: 71335-1677-2: 60 Capsules in a BOTTLE

    NDC: 71335-1677-3: 100 Capsules in a BOTTLE

    NDC: 71335-1677-4: 7 Capsules in a BOTTLE

    NDC: 71335-1677-5: 90 Capsules in a BOTTLE

    Repackaged/Relabeled by:

    Bryant Ranch Prepack, Inc.

    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Docusate Sodium 250 mg Capsule

    Label
  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1677(NDC:57896-426)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (oblong) Size20mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1677-130 in 1 BOTTLE; Type 0: Not a Combination Product07/28/2020
    2NDC:71335-1677-260 in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
    3NDC:71335-1677-3100 in 1 BOTTLE; Type 0: Not a Combination Product04/04/2024
    4NDC:71335-1677-47 in 1 BOTTLE; Type 0: Not a Combination Product08/19/2022
    5NDC:71335-1677-590 in 1 BOTTLE; Type 0: Not a Combination Product04/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/01/2020
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1677) , RELABEL(71335-1677)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!