Label: CARTERS LITTLE PILLS SODIUM-FREE- bisacodyl tablet, delayed release

  • NDC Code(s): 10237-906-25, 10237-906-75
  • Packager: Church & Dwight Co., Inc.
  • 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 November 14, 2018

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

  • Active ingredient (in each tablet)

    Bisacodyl USP, 5 mg


  • Purpose

    Stimulant laxative

  • Uses

    • for relief of occasional constipation (irregularity)
    • this product generally produces a bowel movement in 6 to 12 hours
  • Warnings

    Do not use

    • in children under 6 years of age
    • if your can't swallow without chewing
    • for a period longer than 1 week, unless directed by a doctor
  • Ask a doctor before use if you have

    • stomach pain, nausea, or vomiting
    • a sudden change in bowel habits that persists over 2 weeks

    When using this product

    • do not use within 1 hour after taking an antacid or milk
    • do not chew or crush tablets
    • you may have stomach discomfort, faintness and cramps
  • Stop use and ask a doctor if

    • you need to use a laxative for more than 1 week
    • you fail to have a bowel movement or have rectal bleeding. These could be signs of a serious condition.
  • Keep out of reach of children.

    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

    Follow dosage below or use a directed by a doctor

    adults and children 12 years of age and over                                    1 to 3 tablets (usually 2) in a single daily dose

    children 6 to under 12 years of age                                                  1 tablet in a single daily dose

    children under 6 years of age                                                           consult a doctor

  • Other information

    • avoid excessive humidity
    • store at temperatures not above 86 degrees F (30 C)

    Questions or Comments:  1-800-926-5222 M-F from 9-5 ET

  • Inactive ingredients

    Croscarmellose Sodium, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Methacrylic Acid Copolymer, Microcrystalline Cellulose, Talc, Triacetin, Triethyl Citrate, Zea mays (Corn) Starch


  • Principal Display

    Overnight Relief Guaranteed

    CARTERS

    LITTLE

    PILLS

    Carter's

    BISACODYL DELAYED-RELEASED TABLETS

    STIMULANT LAXATIVE

    Sodium-Free

    ENTERIC COATED 25 TABLETS

    Carton imageCarton image

  • INGREDIENTS AND APPEARANCE
    CARTERS LITTLE PILLS  SODIUM-FREE
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-906
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code C;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-906-251 in 1 CARTON06/01/201111/14/2018
    125 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:10237-906-753 in 1 CARTON06/01/201111/14/2018
    225 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 finalpart33406/01/2011
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Canada Corp.253933600manufacture(10237-906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Seal Corporation085752004repack(10237-906)