Label: LAXATIVE SENNA- sennosides tablet, 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 March 5, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a 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 habits that continues over a period of 2 weeks

    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.

    If pregnant 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.

  • Directions

    • take preferably at bedtime or as directed by a doctor
    agestarting dosagemaximum dosage
    adults and children 12 years of age and over2 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
  • Other information

    • each tablet contains: calcium 27.93 mg, magnesium 0.19 mg
    • store between 20-25 °C (68-77 °F)
  • Inactive ingredients

    crosscarmellose sodium, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, talc, triacetin

  • Questions or comments

    Call: 1-888-577-8033

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO
    ASSOCIATES LLC, ELK GROVE
    VILLAGE, IL 60007

  • PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Carton

    *Compare to SENOKOT®,
    Active ingredient
    NDC 36800-165-01

    Vegetable
    Laxative

    Sennosides 8.6 mg

    • Laxative
    • Gentle, Overnight relief of
      constipation

    100
    TABLETS

    Principal Display Panel - 100 mg Tablet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    LAXATIVE SENNA 
    sennosides tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-984
    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)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Talc (UNII: 7SEV7J4R1U)  
    Triacetin (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code S155
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-984-011 in 1 CARTON05/01/2021
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33405/01/2021
    Labeler - TOPCO ASSOCIATES LLC (006935977)