Label: DQZATE STOOL SOFTENER- docusate sodium capsule, gelatin coated

  • 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 16, 2020

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  • Warnings

    Do Not use if you are presently taking mineral oils unless told to do so by a doctor.

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool softener laxative

  • Uses

    relief of occasional constipation (irregularity)

    generally produces bowel movement in 12 to 72 hours

  • If pregnant or breast-feeding

    ask a doctor before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Stop use and ask a doctor

    If you have rectal bleeding

    If you fail to have bowel movement after use of a laxative

    If you need to use a stool softner laxative for more than a week

  • Directions

    Adults and children 12 years and over:Take 1-3 Capsules once daily or in divided doses.

    Children 6 years to under 12:Take one capsule once a day.

    Children under 6 years: Ask your Doctor.

  • Other information

    each softgel contains: sodium 7 mg

    keep tightlyl closed

    store at room temperature 15°-30°C (59°-86°F) in a dry place

  • Inactive ingredients

    FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, sorbitol,purified water

  • DQZate

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    DQZATE STOOL SOFTENER 
    docusate sodium capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53149-1001
    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 (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorredScoreno score
    ShapecapsuleSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53149-1001-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/01/2019
    Labeler - All Pharma LLC (078572520)
    Establishment
    NameAddressID/FEIBusiness Operations
    All Pharma LLC078572520label(53149-1001)
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