Label: SENOKOTXTRA- standardized senna concentrate tablet

  • 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 February 5, 2014

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  • Drug Facts Active ingredient (in each tablet) Purpose

    Sennosides 17.2 mg

  • Purpose

    Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally causes bowel movement in 6-12 hours
  • Warnings

  • Do not use

    • laxative products for longer than 1 week unless directed by a doctor
  • Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel movements that continues over a period of 2 weeks
  • STOP USE

    Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health 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.

  • Directions

    • take preferably at bedtime or as directed by a doctor
    agestarting dosagemaximum dosage
    adults and children 12 years of age and over1 tablet
    once a day
    2 tablets
    twice a day
    children 6 to under 12 years1/2 tablet
    once a day
    1 tablet
    twice a day
    children under 6ask a doctorask a doctor
  • Other information

    • each tablet contains: calcium 20 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients croscarmellose sodium, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, stearic acid, talc, tartaric acid

  • SPL UNCLASSIFIED SECTION

    ©2011, Purdue Products L.P.

    Dist. by: Purdue Products L.P., Stamford, CT 06901-3431


    302602-0A

  • PRINCIPAL DISPLAY PANEL

    SenokotXTRA

    12 Tablets

    SenokotXTRA Tablets NDC 67618-315-12
  • INGREDIENTS AND APPEARANCE
    SENOKOTXTRA 
    standardized senna concentrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-315
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES17.2 mg
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium (UNII: M28OL1HH48)  
    anhydrous lactose (UNII: 3SY5LH9PMK)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    mineral oil (UNII: T5L8T28FGP)  
    stearic acid (UNII: 4ELV7Z65AP)  
    tartaric acid (UNII: W4888I119H)  
    hypromelloses (UNII: 3NXW29V3WO)  
    anhydrous dibasic calcium phosphate (UNII: L11K75P92J)  
    Product Characteristics
    ColorBROWN (Light Brown) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code X
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-315-121 in 1 CARTON09/01/1988
    112 in 1 BLISTER PACK
    2NDC:67618-315-363 in 1 CARTON09/01/198801/01/2014
    212 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/01/1988
    Labeler - Purdue Products LP (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corporation968334974MANUFACTURE(67618-315)