Label: LAXATIVE- bisacodyl tablet, delayed release

  • NDC Code(s): 56062-976-01
  • Packager: Publix Super Markets Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 21, 2024

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  • Active ingredient (in each tablet)

    Bisacodyl USP, 5 mg

  • Purpose

    Stimulant laxative

  • Uses

    • for relief of occasional constipation (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

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

    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, and cramps

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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

    • do not take more than directed
    • take with a glass of water
    adults and children 12
    years and over    		take 1 to 3 tablets in a
    single daily dose
    children 6 to under 12
    years    		take 1 tablet in a single
    daily dose
    children under 6 yearsask a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • avoid excessive humidity
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

  • Principal display panel

    NDC 56062-976-01

    P

    laxative
    BISACODYL USP, 5 mg
    STIMULANT LAXATIVE

    • Gentle, dependable constipation relief

    30
    COMFORT
    COATED TABLETS

    ACTUAL SIZE

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    50844      REV0923A67601

    DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
    3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811
    1-888-267-3037 publix.com

    PUBLIX GUARANTEE: COMPLETE
    SATISFACTION OR YOUR MONEY BACK

    Publix®

    Publix 44-676A

    Publix 44-676A

  • INGREDIENTS AND APPEARANCE
    LAXATIVE 
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-976
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-976-012 in 1 CARTON05/21/2024
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/21/2024
    Labeler - Publix Super Markets Inc (006922009)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(56062-976)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(56062-976) , pack(56062-976)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(56062-976)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(56062-976)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(56062-976)
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