Label: DOCUSATE SODIUM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 31, 2020

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

  • Active ingredient (in each softgel)

    Docusate Sodium 100mg

  • Purpose

    Stool Softener

  • Uses

    for the prevention of dry, hard stools
    for relief of occasional constipation.
    This product 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
    for longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have noticed 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
    you fail to have a bowel movement after use

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

    This unit dose package is not child resistant and is Intended for Institutional Use Only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    This package is intended for institutional use only.

    Consult a physician before the use of this product.

  • Directions

    Adults and children over 12 years of age and over: take 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses
    Children 2 to under 12 years of age take 1 softgels daily
    Children under 2 years of age: Consult a physician
  • Other information

    each capsule contains: sodium 5 mg
    store at controlled room temperature 15° - 30°C (59° - 86°F)
  • Inactive ingredients

    FD&C Red No. 40, FD&C Yellow No.6, Gelatin, Bovine Bone, Glycerol Palm Free, Polyethylene Glycol 400 NF, Purified Water, Sorbitol Special 76%.

    SKY

    Mfg. By:

    Aenova Holding GmbH

    14193 SW 119th Ave.,

    Miami, FL 33186-6013

    Distributed by

    McKesson Packaging Services

    a business unit of McKesson Corporation

    7101 Weddington Road

    Concord, NC 28027

    Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids

    www.PROmanager-Rx.com

    Distributed by

    Cardinal Health

    Dublin, OH 43017

    L44377781018

  • Principal Display Panel - Bag

    Docusate Sodium 100 MG Softgels

    10 Softgels

    bag label
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1485(NDC:63739-478)
    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)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorRED (Reddish) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-1485-010 in 1 BAG11/08/2010
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other11/08/2010
    Labeler - Cardinal Health (603638201)