Label: SENNOSIDE 8.6MG tablet, film coated

  • Category: HUMAN OTC DRUG LABEL

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 November 16, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Sennoside 8.6mg

  • INACTIVE INGREDIENT

    croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, magnesium stearate, polyethylene glycol

  • DOSAGE & ADMINISTRATION

    • do not take more than directed
    • take with full glass of water
    • 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

  • INDICATIONS & USAGE

    • relieves occasional constipation (irregularity)
    • generally causes 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
    • notice a sudden change in bowel habits that continue 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

    Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Incase of accidental overdose, get medical help or contact a Poison Contril Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • PURPOSE

    Laxative

  • OTHER SAFETY INFORMATION

    • Store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF).
  • PRINCIPAL DISPLAY PANEL

    CT11241

  • INGREDIENTS AND APPEARANCE
    SENNOSIDE 8.6MG 
    sennoside 8.6mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Product Characteristics
    ColorgrayScoreno score
    ShapeROUND (BICONVEX) Size5mm
    FlavorImprint Code S3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-112-414 in 1 PACKAGE; Type 0: Not a Combination Product12/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/20/2018
    Labeler - Strive Pharmaceuticals Inc. (080028013)