Label: DULCOLAX STOOL SOFTENER- docusate sodium capsule, liquid filled

  • NDC Code(s): 41167-0221-2, 41167-0221-3, 41167-0221-4, 41167-0221-9
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Dulcolax®

    Stool Softener Carton

    Drug Facts

  • Active ingredient (in each capsule)

    Docusate sodium (USP) 100 mg

  • Purpose

    Stool softener laxative

  • Use

    ● for relief of occasional constipation and irregularity

    ● this product generally produces bowel movement in 12 to 72 hours

  • Warnings

    Do not use

    ● if you are presently taking mineral oil, unless told to do so by a doctor

    Ask a doctor before use if you have

    ● stomach pain, nausea or vomiting

    ● a sudden change in bowel habits that lasts more than 2 weeks

    Stop use and ask a doctor if

    ● you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition. 

    ● you need to use a laxative for more than 1 week

    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 with a glass of water

    adults and children 12 years of age and over                   1 to 3 capsules daily. This dose may be taken as a single daily dose or in divided doses.

    children 2 to under 12 years of age                                  1 capsule daily

    children under 2 years of age                                           ask a doctor

  • Other information

    ● each capsule contains: sodium 6 mg

    ● store at 20°-25°C (68°-77°F). Protect from excessive humidity

    ● contains FD&C Yellow No. 6

    ● do not use this product if the safety seal under the cap is torn or missing

  • Inactive ingredients

    FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, water

  • Questions?

    Call 1-866-844-2798 or visit www.Dulcolax.com

    Keep carton as it contains important product information.

  • PRINCIPAL DISPLAY PANEL

    Dulcolax

    Stool Softener

    25 Liquid Gels

    Dulcolax Stool Softener 25 Liquid Gels

  • INGREDIENTS AND APPEARANCE
    DULCOLAX STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0221
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code Dulcolax
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0221-41 in 1 CARTON08/01/2020
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41167-0221-21 in 1 CARTON08/01/2020
    225 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:41167-0221-31 in 1 CARTON08/01/2020
    350 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41167-0221-91 in 1 CARTON08/01/2020
    430 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/01/2020
    Labeler - Chattem, Inc. (003336013)
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