Label: STOOL SOFTENER WITH STIMULANT LAXATIVE- docusate sodium, sennosides tablet

  • NDC Code(s): 55319-084-01
  • Packager: Family Dollar (FAMILY WELLNESS)
  • 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 October 20, 2021

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  • Active ingredients (in each tablet)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool softener

    Stimulant laxative

  • Uses

    • for overnight relief from occasional constipation (irregularity)
    • 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 now 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 a period of  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 may indicate 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 over take 2-4 tablets daily
     children 6 to under 12 years of age take 1-2 tablets daily
     children 2 to under 6 years of age take up to 1 tablet daily
     children under 2 ask a doctor


  • Other information

    • each tablet contains: calcium 20 mg
    • each tablet contains: sodium 6 mg VERY LOW SODIUM
    • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
  • Inactive ingredients

    carnauba wax*, croscarmellose sodium, dibasic calcium pjosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red # 40 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

    *contains one or more of these ingredients

  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENTS OF PERI-COLACE®†

    Stool Softener

    With Stimulant Laxative

    Docusate sodium 50 mg

    Sennosides 8.6 mg

    Relieves Constipation

    TABLETS

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    †This product is not manufactured ir distributed by Purdue Products L.P distributor of Peri-Colace®.

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC

    10611 MONROE RD., MATTHEWS, NC 28105

  • Product Label

    Docusate Sodium 50 mg, Sennosides 8.6 mg

    FAMILY WELLNESS Stool Softener

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER WITH STIMULANT LAXATIVE 
    docusate sodium, sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-084
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL097;0806;AV;S44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-084-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/201504/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/30/201504/26/2024
    Labeler - Family Dollar (FAMILY WELLNESS) (024472631)
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