Label: MEDIQUE MEDI-LAX ENTERIC COATED- bisacodyl 5 mg tablet, sugar coated

  • NDC Code(s): 47682-859-05
  • Packager: Unifirst First Aid Corporation
  • 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 16, 2022

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  • Drug Facts

  • Active ingredient (in each tablet)

    Bisacodyl USP 5 mg

  • Purpose

    Stimulant laxative

  • Uses

    • for the temporary relief of occasional constipation and irregularity
    • this product generally produces bowel movement in 6 to 12 hours
  • Warnings

    Do not use if you cannot swallow without chewing.

    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

    When using this product

    • do not chew or crush tablet(s)
    • do not use within 1 hour after taking an antacid or milk
    • it may cause stomach discomfort, faintness or cramps

    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.
    • 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 (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years and older: 1 to 3 tablets in a single daily dose

    Children under 12 years: do not give to children under 12 years of age

  • Other information

    • store between 68º to 77ºF (20º to 25ºC)
    • tamper evident sealed blister pack(s)
    • do not use if a blister unit is torn, broken or shows any signs of tampering
  • Inactive ingredients

    acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C Yellow #10 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments

    Call 1-800-634-7680

  • Medique Medi-lax Label

    Medique®

    Medi-lax

    Stimulant Laxative

    Bisacodyl Delayed-Release Tablets USP, 5 mg

    *Compare to the active ingredients in Ducolax®

    Enteric Coated Tablets

    Tamper Evident Blister Pack

    25 Tablets

    MDQ

  • INGREDIENTS AND APPEARANCE
    MEDIQUE MEDI-LAX ENTERIC COATED 
    bisacodyl 5 mg tablet, sugar coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-859
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    TALC (UNII: 7SEV7J4R1U)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SUCROSE (UNII: C151H8M554)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ACACIA (UNII: 5C5403N26O)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    AMMONIA (UNII: 5138Q19F1X)  
    POVIDONE (UNII: FZ989GH94E)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-859-051 in 1 BOX07/01/2020
    125 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/01/2020
    Labeler - Unifirst First Aid Corporation (832947092)
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