Label: STOOL SOFTENER- docusate sodium capsule, liquid filled

  • NDC Code(s): 57896-426-01
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

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  • 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

  • package Label

    1

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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 (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:57896-426-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/01/2020
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
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