Label: P LAX DR- bisacodyl tablet, sugar 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 April 21, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each tablet)

    Bisacodyl 5 mg

  • Purpose

    Stimulant laxative

  • Uses

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

    Do not use for children under 6 years of age

    Ask a doctor before use if you have

    • abdominal pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that persists over a period of 2 weeks

    Ask a doctor or pharmacist before use if you are unable to swallow without chewing

    When using this product

    • do not chew or crush tablets
    • do not take this product within 1 hour after taking an antacid or milk
    • abdonimal discomfort,faintness, and cramps may occur

    Stop use and ask doctor if

    • you need to use more than 1 week
    • rectal bleeding or failure to have a bowel movement occur after use of a laxative.These may be signs of a serious condition

    If pregana 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.

  • Direction

    • each laxative works differently.Adults and children over 12 may need fewer tablets to get the same effect as more tablets of another brand.
    • Start with one tablet and take with water.If one tablet does not produce the desired result,then try two or three tablets daily.
    • Do not take more than three tablets daily
    adults and children 12 years of age and older- take 1 to 3 tablets in a single dose once daily
    children 6 to under 12 years of age- take 1 tablet once daily
    children under 6 years of age- ask a doctor
  • Other information

    • each tablet contains : calcium 20 mg
    • do not exposee to temperatures above 30°C(85°F)
    • store between 20° to 25°C (68° to 77° F)
  • Inactive ingredients

    lactose,cornstarch,povidone (K-30),sodium startch glycolate,talc,magnesium stearate,methcylic acidcopolymer,polethylene glaycol,sodium hydroxide,sucrose,acacia,gelatin,methylparaben,propylparaben,calcium sulphate dihydrate,titanium dioxide,D&C red#7 lake, FD & C Red #40; D & C Red # 27

  • PRINCIPAL DISPLAY PANEL - 5 mg Shipping Label

    P LAX TABLETS DR, 5 mg-SUGAR COATED: PINK

    Each Delayed Release Tablet Contains

    (Bisacodyl 5 mg Tablets,USP)

    LOT NO :
    DRUM NO :
    MFG. DATE :

    QUANTITY : 10000
    NDC NO : 68210-0002-1
    EXP. DATE :

    WARNING :
    KEEP OUT OF THE REACH OF CHILDREN

    STORE CONTROLLED ROOM TEMPRATURE OF 59° – 86°F (15° – 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
    CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
    CONFORMANCE WITH THE F.D & C.ACT AND REGULATIONS THEREUNDER

    MANUFACTURED BY:

    LABELLER CODE : 50654
    LIC NO. : 25/5/2009

    MANUFACTURED FOR:
    SPIRIT PHARMACEUTICALS LLC
    225 LINCOLN HWY, STE 205
    FAIRLESS HILLS , PA 19030
    PH.# 215 943 4000, FAX.#215 943 4039

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    PRINCIPAL DISPLAY PANEL - 5mg Shipping Label
  • INGREDIENTS AND APPEARANCE
    P LAX DR 
    bisacodyl tablet, sugar coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    SUCROSE (UNII: C151H8M554)  
    ACACIA (UNII: 5C5403N26O)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0002-11 in 1 DRUM
    110000 in 1 BAG
    2NDC:68210-0002-51 in 1 DRUM
    250000 in 1 BAG
    3NDC:68210-0002-61 in 1 DRUM
    365000 in 1 BAG
    4NDC:68210-0002-71 in 1 DRUM
    470000 in 1 BAG
    5NDC:68210-0002-81 in 1 DRUM
    580000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/01/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MISSION VIVACARE LIMITED677604252API MANUFACTURE, RECOVERY
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