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P LAX DR (SPIRIT PHARMACEUTICALS,LLC)

Available Formats

Dosage Form Package Information Links
TABLET, SUGAR COATED 1 BAG in 1 DRUM (68210-0002-5) > 50000 TABLET, SUGAR COATED in 1 BAG Label Information
TABLET, SUGAR COATED 1 BAG in 1 DRUM (68210-0002-6) > 65000 TABLET, SUGAR COATED in 1 BAG Label Information
TABLET, SUGAR COATED 1 BAG in 1 DRUM (68210-0002-1) > 10000 TABLET, SUGAR COATED in 1 BAG Label Information
TABLET, SUGAR COATED 1 BAG in 1 DRUM (68210-0002-8) > 80000 TABLET, SUGAR COATED in 1 BAG Label Information
TABLET, SUGAR COATED 1 BAG in 1 DRUM (68210-0002-7) > 70000 TABLET, SUGAR COATED in 1 BAG Label Information

Complete P LAX DR Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0002
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color PINK Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68210-0002-1 1 in 1 DRUM
    1 10000 in 1 BAG
    2 NDC:68210-0002-5 1 in 1 DRUM
    2 50000 in 1 BAG
    3 NDC:68210-0002-6 1 in 1 DRUM
    3 65000 in 1 BAG
    4 NDC:68210-0002-7 1 in 1 DRUM
    4 70000 in 1 BAG
    5 NDC:68210-0002-8 1 in 1 DRUM
    5 80000 in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 05/01/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
    Establishment
    Name Address ID/FEI Business Operations
    MISSION VIVACARE LIMITED 677604252 API MANUFACTURE, RECOVERY