Label: STOOL SOFTENER WITH LAXATIVE- docusate sodium and sennosides tablet, film coated

  • NDC Code(s): 57896-304-01, 57896-304-10
  • 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 tablet)

    Docusate Sodium 50 mg
    Sennosides 8.6 mg

  • Purpose

    Stool softener

    Stimulant laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • this product generally produces bowel movement in 6 to 12 hours
  • Warnings

    Do not use

    • laxative products for longer than 1 week unless directed by a doctor
    • if you are presently taking mineral oil, unless directed 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.

    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

    • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
    adults and children 12 years and overtake 2-4 tablets daily
    children under 12 years of ageask a doctor

  • Other information

    • each tablet contains: calcium 20 mg, sodium 3 mg
    • store at controlled room temperature
    • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
    • product of India

  • Inactive ingredients

    cellulose, croscarmellose sodium, dicalcium phosphate, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

  • Package Label

    1

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER WITH LAXATIVE 
    docusate sodium and sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-304
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code PSD21
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-304-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2019
    2NDC:57896-304-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/01/2019
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
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