Label: LAXATIVE- bisacodyl tablet

  • NDC Code(s): 11822-0327-1, 11822-0327-5, 11822-0327-6
  • Packager: Rite Aid
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 05/13

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

  • Active ingredient (in each tablet)

    Bisacodyl 5 mg

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  • Purpose

    Stimulant laxative

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  • Uses

    • relieves occasional constipation and irregularity
    • this product generally produces bowel movement in 6 to 12 hours
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  • 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
    • you may have stomach discomfort, faintness or 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.

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  • Directions

    • 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 of age  take 1 tablet in a single daily dose
     children under 6 years of age  ask a doctor

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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • avoid excessive humidity
    • see end flap for expiration date and lot number
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  • Inactive ingredients

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

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  • Principal Display Panel

    RITE
    AID
    ®
    PHARMACY

    *Compare to the active ingredient in Dulcolax®

    laxative
    bisacodyl USP 5 mg
    stimulant laxative

    gentle, predictable
    overnight relief
    delayed-release tablets
    enteric coated

    200 TABLETS
    5 mg EACH

    *This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax®.
    50844      ORG031232706

    DISTRIBUTED BY:
    RITE AID
    30 HUNTER LANE
    CAMP HILL, PA 17011

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

    Rite Aid 44-327

    Rite Aid 44-327

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  • INGREDIENTS AND APPEARANCE
    LAXATIVE 
    bisacodyl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0327
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISACODYL (BISACODYL) BISACODYL 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA  
    AMMONIA  
    CALCIUM CARBONATE  
    CARNAUBA WAX  
    STARCH, CORN  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    FERROSOFERRIC OXIDE  
    LACTOSE  
    MAGNESIUM STEARATE  
    METHYLPARABEN  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    POVIDONES  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    SHELLAC  
    DIMETHICONE  
    SODIUM ALGINATE  
    SODIUM BENZOATE  
    SODIUM BICARBONATE  
    STEARIC ACID  
    SUCROSE  
    TALC  
    TITANIUM DIOXIDE  
    TRIACETIN  
    TRIETHYL CITRATE  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code 44;327
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0327-5 1 in 1 CARTON
    1 50 in 1 BLISTER PACK
    2 NDC:11822-0327-1 1 in 1 CARTON
    2 100 in 1 BOTTLE, PLASTIC
    3 NDC:11822-0327-6 1 in 1 CARTON
    3 200 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 03/25/2002
    Labeler - Rite Aid (014578892)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(11822-0327)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(11822-0327)
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