Label: WOMENS GENTLE LAXATIVE- bisacodyl tablet, coated

  • 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 03/13

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

  • Active ingredient (in each enteric coated tablet)

    Bisacodyl 5 mg

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  • Purpose

    Stimulant laxative

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  • Uses

    • for gentle, overnight relief of occasional constipation (irregularity)

    • this product generally produces bowel movement in 6 to 12 hours

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  • Warnings

    Do not use

    • in children under 6 years of age

    • in persons who cannot swallow without chewing

    Ask a doctor before use if you have

    • abdominal pain

    • nausea

    • vomiting

    • sudden change in bowel movements that persist over a period of 2 weeks

    When using this product

    • do not use for a period longer than 1 week unless directed by a doctor

    • you may experience abdominal discomfort, faintness and cramps

    Stop use and ask a doctor if

    • rectal bleeding occurs

    • you fail to have a bowel movement

    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

    • do not chew or crush tablets

    • do not take within 1 hour after taking an antacid or milk

     adults and children over 12 years of age oral dosage is 1 to 3 tablets in a single or divided daily dose 
     children 6 to under 12 years of age  oral dosage is 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)

    • protect from moisture

    • see end flap for expiration date and lot number

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  • Inactive ingredients

    acacia, black iron oxide, calcium carbonate, carnauba wax, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose,  lactose, magnesium stearate, methylparahydroxy benzoate, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparahydroxy benzoate, shellac glaze, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

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  • Principal Display Panel

    FRED'S®

    Stimulant Laxative

    Women's
    Gentle Laxative
    Bisacodyl 5 mg
    Gentle, Dependable Overnight Relief

    30 Enteric Coated Tablets

    Tested Against The Active Ingredient In: CORRECTOL®*

    *This product is not manufactured or distributed Schering-Plough Healthcare Products, owner of the registered trademark Correctol®.
    50844        REV0410E32601

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

    Fred's 44-326

    Fred's 44-326


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  • INGREDIENTS AND APPEARANCE
    WOMENS GENTLE LAXATIVE 
    bisacodyl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-326
    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  
    FERROSOFERRIC OXIDE  
    CALCIUM CARBONATE  
    CARNAUBA WAX  
    D&C RED NO. 27  
    FD&C BLUE NO. 2  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    LACTOSE  
    MAGNESIUM STEARATE  
    POLYDEXTROSE  
    POLYETHYLENE GLYCOLS  
    Polyvinyl Acetate Phthalate  
    POVIDONES  
    PROPYLENE GLYCOL  
    SODIUM ALGINATE  
    SODIUM BENZOATE  
    SODIUM BICARBONATE  
    STEARIC ACID  
    SUCROSE  
    TALC  
    TITANIUM DIOXIDE  
    TRIACETIN  
    TRIETHYL CITRATE  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 44;326
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-326-01 1 in 1 CARTON
    1 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 02/12/2005
    Labeler - FRED'S, INC. (005866116)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55315-326)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55315-326)
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