Label: ALOPHEN- bisacodyl tablet, 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 December 28, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient (in each enteric coated tablet)Purpose
    Bisacodyl 5 mgLaxative
  • Use

    for the relief of occasional constipation and irregularity. This product generally produces a bowel movement in 6-12 hours.

  • Warnings

    Do not use

    • unless directed by a doctor, when abdominal pain, nausea, or vomiting are present
    • this product for more than 1 week unless directed by a doctor
    • this product within 1 hour after taking an antacid or milk
    • for children under 6 years of age
    • for persons who can not swallow without chewing
  • Ask a doctor before use if you have

    a sudden change in bowel habits over a period of 2 weeks.

  • When using this product

    • do not chew the tablets
    • it may cause abdominal discomfort, faintness, and cramps
  • Stop use and ask a doctor if

    • rectal bleeding occurs
    • there is failure to have a bowel movement after use of a laxative. These may indicate a serious condition.
  • PREGNANCY OR BREAST FEEDING

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

  • Keep out of reach of children.

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

  • Directions

    • do not chew tablets
    adults and children 12 years of age and over1-3 tablets in a single daily dose
    children 6 to under 12 years of age1 tablet in a single daily dose
    children under 6 years of ageconsult a doctor
  • Other information

    store at temperature not above 86° F(30 C)

  • 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?

    call 1-800-214-2379

  • PRINCIPAL DISPLAY PANEL

    NDC 69846-140-01

    Now Smaller,
    Easier to Swallow


    Alophen®
    (Bisacodyl USP)

    Comfort Coated
    Stimulant Laxative

    Gentle, Effective
    Overnight Relief


    100 Tablets, 5 mg. each

    Do not use if printed "SEALED FOR YOUR PROTECTION" inner seal is broken or missing.

    Dist. by: Numark Brands, Inc.                57001
    EDISON, NJ 08818    1-800-214-2379  Rev. 4/21

    LOT #

    EXP. DATE
     

    Carton

    NDC 69846-140-01

    Now Smaller, Easier to Swallow

    Alophen®
    (Bisacodyl USP)

    Comfort Coated
    Stimulant Laxative

    Gentle, Effective
    Overnight Relief


    100 Tablets, 5 mg. each

    REFER TO OUTER CARTON FOR FULL INFORMATION

    Distributed by: Numark Brands, Inc.
    EDISON, NJ 08818    1-800-214-2379     57000    Rev. 1/21

    LOT #

    EXP. DATE

    Label
  • INGREDIENTS AND APPEARANCE
    ALOPHEN  
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69846-140
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bisacodyl (UNII: 10X0709Y6I) (Deacetylbisacodyl - UNII:R09078E41Y) Bisacodyl5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Acacia (UNII: 5C5403N26O)  
    Ammonia (UNII: 5138Q19F1X)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Starch, Corn (UNII: O8232NY3SJ)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Fd&C Yellow No. 6 (UNII: H77VEI93A8)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Anhydrous Lactose (UNII: 3SY5LH9PMK)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Polydextrose (UNII: VH2XOU12IE)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Shellac (UNII: 46N107B71O)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Sodium Alginate (UNII: C269C4G2ZQ)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Sucrose (UNII: C151H8M554)  
    Talc (UNII: 7SEV7J4R1U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Triacetin (UNII: XHX3C3X673)  
    Triethyl Citrate (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorYELLOW, ORANGEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code TCL;003
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69846-140-011 in 1 CARTON04/15/1907
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/15/1907
    Labeler - NUMARK BRANDS, INC (080184668)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULTRA SEAL CORPORATION085752004manufacture(69846-140)