Label: PHILLIPS STOOL SOFTENER BULK DOCUSATE- docusate sodium capsule, liquid filled

  • NDC Code(s): 0280-1012-30, 0280-1012-60
  • Packager: Bayer HealthCare LLC.
  • 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 31, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

  • Purpose

    Stool softener laxative

  • Use

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

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if you have

    • stomach pain, nausea, or vomiting
    • a sudden change in bowel habits that lasts over 14 days

    Ask a doctor or pharmacist before use if you are presently taking mineral oil

    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 softgels with a full glass (8 oz) of water
    adults and children 12 years and oldertake 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses.
    children 6 to under 12 yearstake 1 softgel daily or as directed by a doctor
    children under 6 years of ageask a doctor
  • Other information

    • each softgel contains: sodium 6 mg
    • very low sodium
    • store at room temperature. Avoid excessive heat 40°C (104°F).
  • Inactive ingredients

    FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.bayercare.com

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Carton

    PHILIPS_Stoolsoftener_DS_LiquidGel_30ct_Tab_Crtn

  • INGREDIENTS AND APPEARANCE
    PHILLIPS STOOL SOFTENER  BULK DOCUSATE
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1012
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize4mm
    FlavorImprint Code P10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-1012-301 in 1 CARTON05/19/2015
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0280-1012-601 in 1 CARTON05/19/2015
    260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/02/201312/01/2023
    Labeler - Bayer HealthCare LLC. (112117283)