Label: DOCUSATE SODIUM capsule, liquid filled

  • NDC Code(s): 60687-129-01, 60687-129-11
  • Packager: American Health Packaging
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2024

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  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool softener laxative

  • Uses

    • for relief of occasional constipation (irregularity)
    • generally produces a bowel movement within 12 to 72 hours
  • Warnings

    Do not use

    • if you are currently taking mineral oil, unless directed by a doctor
    • when abdominal pain, nausea or vomiting are present unless directed by a doctor
    • for longer than one week unless directed by a doctor

    Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

    Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.

    If pregnant or breast-feeding, ask a health care professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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 or in divided doses.

    adults and children 12 years of age and over

    take 1 to 3 softgels daily

    children 2 to under 12 years of age

    take 1 softgel daily

    children under 2 years of age

    ask a doctor
  • Other information

    • Each softgel contains: sodium 7 mg VERY LOW SODIUM
    • Store at room temperature between 15° to 30°C (59° to 86°F)
    • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
  • Inactive ingredients

    FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP

    The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl.

    Distributed by:
    American Health Packaging
    2550 John Glenn Avenue, Suite A
    Columbus, OH 43217

    712901
    0412901/0216PS

  • Principal Display Panel – Carton – 100 mg

    100 mg Docusate Sodium Softgels Carton Label

    NDC 60687- 129-01

    DOCUSATE SODIUM, USP
    Stool Softener Laxative

    100 mg

    100 Softgels (10 x 10)

    The drug product contained in this package is from
    NDC # 61301-8001, SWISSCAPS Romania srl.

    Packaged and Distributed by:
    American Health Packaging
    Columbus, OH 43217

    712901
    0412901/0119

  • Principal Display Panel - Blister – 100 mg

    100 mg Docusate Sodium Softgel Blister

    DOCUSATE SODIUM, USP
    Stool Softener Laxative
    Softgel    100 mg

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-129
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorred (Reddish) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60687-129-01100 in 1 BOX, UNIT-DOSE01/19/2016
    1NDC:60687-129-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00701/19/2016
    Labeler - American Health Packaging (929561009)
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