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

Drug Label Information

Updated October 24, 2024

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  • 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 CARTON05/19/201512/01/2023
    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 DrugM00709/02/2013
    Labeler - Bayer HealthCare LLC. (112117283)
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