Label: DYRAX-Q TAB- bisacodyl, docusate sodium tablet

  • NDC Code(s): 58354-117-01, 58354-117-02
  • Packager: Cho-A Pharm.Co.,Ltd.
  • 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 March 15, 2023

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  • Active Ingredients

    Bisacodyl 5 mg

    Docusate Sodium 16.75 mg

  • Purpose

    Laxative

  • Keep out of reach of children

    If swallowed, get medical help or contact Poison Control Center right away.

  • Uses

    For temporary relief of occasional constipation and irregularity

  • Warnings

    For external use only

    Ask a doctor before use if you have

    stomach pain, nausea or vomiting,
    a sudden change in bowel habits that lasts more than 2 weeks

    If Pregnant or breast-feeding, ask a health professional before use.

  • Directions

    adults and children 15 years and older

    2 tablets at once per day (at bedtime)

    children 12 – 14 years

    1 1/3 tablet at once per day (at bedtime)

    children 8 – 11 years

    1 tablet at once per day (at bedtime)

  • Inactive Ingredients

    Corn Starch, Colloidal Silicon Dioxide, Ethanol, Hydroxypropylcellulose, Lactose Hydrate, Magnesium Stearate, Sodium Lauryl Sulfate, OPADRY OY-C-7000A WHITE, ACRYL-EZE White, Food Yellow No.203, Food Blue No.1, Purified Water, Ursodesoxycholic Acid.

  • Dyrax-Q Tab

    Dyrax-Q Tab

  • INGREDIENTS AND APPEARANCE
    DYRAX-Q TAB 
    bisacodyl, docusate sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58354-117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg  in 161 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM16.75 mg  in 161 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58354-117-021 in 1 BOX10/25/201910/26/2019
    1NDC:58354-117-011 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/25/2019
    Labeler - Cho-A Pharm.Co.,Ltd. (688056831)
    Registrant - Cho-A Pharm.Co.,Ltd. (688056831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cho-A Pharm.Co.,Ltd.688056831manufacture(58354-117)
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