Label: BISACODYL tablet, delayed release

  • NDC Code(s): 24689-129-02, 24689-129-03, 24689-129-04, 24689-129-05
  • Packager: Apnar Pharma LP
  • 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 4, 2022

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Bisacodyl (USP) 5 mg

  • PURPOSE

    Purpose

    Stimulant laxative

  • INDICATIONS & USAGE

    ​Uses

    • for relief of occasional constipation and irregularity
    • this product generally produces bowel movement in 6 to 12 hours
  • WARNINGS

    Warnings

    Do not use

    • if you cannot swallow without chewing

    Ask a doctor before use if you have:

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

    When using this product

    • it may cause stomach discomfort, faintness and cramps
    • do not chew or crush tablets(s)
    • do not use within 1 hour after taking antacid or milk

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after using this product. 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 care professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • take with glass of water
    • adult and children 12 years of age and over- 1 to 3 tablets 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- ask a doctor
  • STORAGE AND HANDLING

    Other Information

    • store at 15º-30ºC (59º - 86º F).
  • INACTIVE INGREDIENT

    Inactive ingredients

    Lactose monohydrate, Anhydrous lactose, Pregelatinized starch, Magnesium stearate, Hypromellose, Triacetin, Talc, Methacrylic acid-ethyl acrylate copolymer (1:1) Type-A, Titanium dioxide, Triethyl citrate, D&C red no. 27, Colloidal anhydrous silica, Sodium bicarbonate, Sodium lauryl sulfate, FD&C blue no. 1, Carboxymethyl cellulose sodium, Maltodextrin, Dextrose monohydrate, Lecithin Soya.

  • QUESTIONS

    Questions or comments?

    • 1-855-642-2594
  • SPL UNCLASSIFIED SECTION

    Distributed By:

    APNAR PHARMA LP

    CHINO, CA, 91710

    Rev.: 07/2022

    Compare to Dulcolax Pink®

    active ingredient*

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

  • BOXED WARNING (What is this?)

    Caution: Do not use if imprinted seal under cap is broken or missing.

  • PRINCIPAL DISPLAY PANEL

    NDC 24689-129-02

    Bisacodyl Delayed Release Tablets USP

    5 mg- Pink

    Stimulant Laxative

    20 Tablets

    NDC 24689-129-02 Bisacodyl Delayed Release Tablets USP 5 mg- Pink 20 Tablets 300072

    NDC 24689-129-03

    Bisacodyl Delayed Release Tablets USP

    5 mg- Pink

    Stimulant Laxative

    100 Tablets

    Bisacodyl DR Tablets - 5 mg -100s count label

    NDC 24689-129-04

    Bisacodyl Delayed Release Tablets USP

    5 mg- Pink

    Stimulant Laxative

    250 Tablets

    Bisacodyl DR Tablets - 5 mg -250s count label

    NDC 24689-129-05

    Bisacodyl Delayed Release Tablets USP

    5 mg- Pink

    Stimulant Laxative

    500 Tablets

    Bisacodyl DR Tablets - 5 mg -500s count label

  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-129
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    TRIACETIN (UNII: XHX3C3X673)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code F
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-129-0220 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2022
    2NDC:24689-129-03100 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2022
    3NDC:24689-129-04250 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2022
    4NDC:24689-129-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/21/2022
    Labeler - Apnar Pharma LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apnar Pharma Private Limited876730408manufacture(24689-129) , pack(24689-129) , analysis(24689-129)
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