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
  • 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 October 5, 2020

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

  • 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-DOSE11/25/2015
    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 not finalpart33411/25/2015
    Labeler - American Health Packaging (929561009)
    Registrant - Swiss Caps Romania (565466997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss Caps Romania565466997manufacture(60687-129)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Health Packaging929561009repack(60687-129)