Label: DOCUSATE SODIUM, SENNOSIDES tablet, film coated

  • NDC Code(s): 69842-520-01, 69842-520-04, 69842-520-25
  • Packager: CVS Pharmacy, Inc.
  • 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 17, 2020

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

  • Drug Facts

    Active ingredients (in each tablet)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • PURPOSE

    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 older

      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 11 mg
    • each tablet contains: sodium 4 mg
    •  store at 25°C (77°F), protect from heat, light, and moisture
  • INACTIVE INGREDIENT

    croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide, triacetin

  • Questions or comments?

    Call 1-800-231-4670 Monday - Friday 9AM-5PM EST

  • SPL UNCLASSIFIED SECTION

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

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2018 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    V-30287

    *This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace® 2-IN-1.

  • PRINCIPAL DISPLAY PANEL

    CVS Health

    Compare to the active ingredients in Colace® 2-IN-1*

    Stool Softener

    DOCUSATE SODIUM 50 mg

    SENNOSIDES 8.6 mg

    Plus stimulant laxative

    Convenient and predictable overnight relief of constipation

    400 Tablets

    3052C-label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM, SENNOSIDES 
    docusate sodium, sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-520
    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
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code CPC;490
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-520-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/03/201804/30/2022
    2NDC:69842-520-04400 in 1 BOTTLE; Type 0: Not a Combination Product07/03/201804/30/2022
    3NDC:69842-520-25250 in 1 BOTTLE; Type 0: Not a Combination Product07/03/201804/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/03/201804/30/2022
    Labeler - CVS Pharmacy, Inc. (062312574)