Label: STOOL SOFTENER- docusate sodium capsule, liquid filled

  • NDC Code(s): 57896-401-01, 57896-401-03, 57896-401-10, 57896-401-20, view more
    57896-401-25
  • Packager: Geri-Care Pharmaceutical Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 19, 2023

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  • 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

    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

    • do not exceed recommended dose
    • adults and children 12 years and older: take 1-3 softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor.
    • children under 12: ask a doctor
  • Other information

    • each softgel contains: sodium 7 mg. Very low sodium
    • store at 59°-77°F (15°-25°C)
    • keep tightly closed
    • 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, sorbitol special, water.

  • 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:57896-401
    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)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    Colorred (reddish) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-401-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    2NDC:57896-401-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    3NDC:57896-401-0330 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    4NDC:57896-401-20200 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    5NDC:57896-401-25250 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00701/01/2000
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
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