Label: DOCUSATE SODIUM capsule, liquid filled

  • 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 January 13, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg 

  • Purpose

    Stool Softner laxative

  • Uses

    • for temporary relief of occasional constipation and irregularity
    • this product generally produces a bowel movement within 12 to 72 hours
  • WARNINGS

    Warnings

  • Ask a doctor before use if you have

    • stomach pain, nausea or vomittiong
    •  a sudden change in bowel habits that lasts more than 2 weeks
  • ASK DOCTOR/PHARMACIST

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

  • Stop use and ask a doctor if you

    • you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
    • yo need to use laxative for more than 1 week
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health 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.1(800)222-1222

  • Directions

    take with a glass of water

    Adults and children 12 years and over

    1 to 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

    1 softgel daily.

    Children under 2 years of age

    Ask a doctor

  • Other information

    • Store at room temperature 20-25°C  (68-77°F) 
    • protect from excessive humidity
    • do not use this product of the safety seal under the cap is torn or missing
  • Inactive ingredients

    FD&C Red#40, FD&C Yellow#6, gelatin,glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL- Valumeds Stool Softener 30 softels Bottle Labels-Single Tone

    VALUMEDS TM

    Compare to the active ingredient in

    Dulcolax  ® Stool Softener  *

    STOOL  SOFTENER

    DOCUSATE SODIUM 100 mg

    Gentle,Stimulant-Free Relief
    Constipation Relief

    30 SOFTGELS

    Docusate sodium-Single Tone

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0317
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code 125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0317-31 in 1 CARTON04/10/2018
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/10/2018
    Labeler - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LIMITED677385498manufacture(68210-0317)
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