Label: SENOKOT- standardized senna concentrate tablet

  • NDC Code(s): 67618-300-10, 67618-300-20, 67618-300-50
  • Packager: Avrio Health L.P.
  • 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 December 17, 2021

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • INDICATIONS & USAGE

    Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 6–12 hours
  • WARNINGS

    Warnings

  • DO NOT USE

    Do not use

    • laxative products for longer than 1 week unless directed by a doctor
  • ASK DOCTOR/PHARMACIST

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • take preferably at bedtime or as directed by a doctor
    agestarting dosagemaximum dosage
    adults and children
    12 years of age and over
    2 tablets once a day4 tablets twice a day
    children 6 to under 12 years1 tablet once a day2 tablets twice a day
    children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
    children under 2 yearsask a doctorask a doctor
  • SPL UNCLASSIFIED SECTION

    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, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, talc

  • SPL UNCLASSIFIED SECTION

    ©2020

    Avrio Health L.P.

    305616-0B

  • PRINCIPAL DISPLAY PANEL

    50 Tablets
    NDC 67618-300-50

    Senokot 50 Tablets Package
  • INGREDIENTS AND APPEARANCE
    SENOKOT 
    standardized senna concentrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-300
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-300-202 in 1 CARTON06/01/1956
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:67618-300-501 in 1 CARTON06/01/1956
    250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:67618-300-101 in 1 CARTON06/01/1956
    3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/01/1956
    Labeler - Avrio Health L.P. (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Pharmacal Corporation968334974MANUFACTURE(67618-300)