Label: STOOL SOFTENER PLUS STIMULANT LAXATIVE- docusate sodium and sennosides tablet

  • 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 November 11, 2022

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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 told to do so 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 oldertake 2-4 tablets daily 
    children 6 to under 12 years of agetake 1-2 tablets daily 
    children 2 to under 6 years of agetake up to 1 tablet daily 
    children under 2ask 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 phosphate dihydrate, FD&C blue#2, aluminum lake, FD&C red #40 aluminum lake*, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, sillicon dioxide, sodium benzoate, stearic acid, talc*, titanium dioxide

    *contains one or more of these ingredients

  • Questions or comments?

    Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

  • Principal Display Panel

    COMPARE TO Colace® 2-IN-1 active ingredients†

    Stool Softener

    Plus Stimulant Laxative

    DOCUSATE SODIUM 50 mg

    SENNOSIDES 8.6 mg

    For overnight relief of occasional constipation

    • Gentle
    • Dependable

    Relief in 6-12 hours

    TABLETS

    †This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.

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

    DISTRIBUTED BY

    BETTER LIVING BRANDS LLC, P.O. BOX 99

    PLEASANTON, CA 94566-0009

    www.betterlivingbrandsLLC.com

  • Product Label

    Docusate Sodium 50 mg, Sennosides 8.6 mg

    SIGNATURE CARE Stool Softener Plus Stimulant Laxative

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER  PLUS STIMULANT LAXATIVE
    docusate sodium and sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-829
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code TCL097;PSD21;S44
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-829-20200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/31/2018
    Labeler - Safeway, Inc. (009137209)
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