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
  • 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 March 8, 2021

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  • SPL UNCLASSIFIED SECTION

    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 NOT FINALpart33408/01/2020
    Labeler - Chattem, Inc. (003336013)
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