Label: VEGETABLE LAXATIVE- sennosides, 8.6 mg tablet, film coated

  • NDC Code(s): 63561-0188-1
  • Packager: Granulation Technology, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Drug Facts

  • Active ingredients (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 using 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 (1-800-222-1222) right away.

  • 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

  • Other information

    • Each tablet contains:Calcium 27.93 mg
    • Store between 20-25°C (68-77°F)
  • Inactive ingredients

    croscarmellose sodium,dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol (PEG) 4000, talc

  • Principal Display Panel

    NDC 63561-0188-1

    Vegetable Laxative Label

    SENNOSIDES, 8.6 mg LAXATIVE


    Compare to Senokot ® Regular Strength Active Ingredients

    100 Film-Coated Tablets

    Sennosides, 25 mg

    Sennosides, 25 mg_peel

  • INGREDIENTS AND APPEARANCE
    VEGETABLE LAXATIVE 
    sennosides, 8.6 mg tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63561-0188
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G188
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63561-0188-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/17/2024
    Labeler - Granulation Technology, Inc. (847132193)
    Registrant - Granulation Technology, Inc. (847132193)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granulation Technology, Inc.847132193manufacture(63561-0188)
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