Label: DOCUSATE SODIUM- stool softener capsule, liquid filled

  • NDC Code(s): 57896-425-01
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 25, 2017

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

  • Active ingredient (in each softgel)

    Docusate Sodium 250 mg

  • Purpose

    Stool Softener Laxative

  • 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

    • follow directions below or as directed by your physician
    • do not exceed recommended dose
    Adults and children 12 years of age and olderTake one softgel daily
    children under 12Do not use
  • Other information

    • each softgel contains: sodium 15 mg
    • store at room temperature, 15°-30°C (59°-86°F)
    • product of Canada
    • Package not child resistant
    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • Inactive ingredients

    edible ink, FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, propylene glycol, sorbitol sorbitan solution, water

  • package Label

    G

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    stool softener capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-425
    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
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVAL (capsule) Size23mm
    FlavorImprint Code GC425
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-425-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/01/2016
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)