Label: SENOKOT- standardized senna concentrate tablet

  • NDC Code(s): 67618-300-10, 67618-300-20, 67618-300-50
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

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  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredient (in each tablet)

    Sennosides 8.6mg

  • 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

    Aska doctor before use if you have

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

    Stop use and ask a doctorif you have rectal bleeding or fail to have a bowel movementafter 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 ControlCenter 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 oncea day4 tablets twicea day
    children 6 to under12 years1 tablet once aday2 tablets twicea day
    children 2 to under6 years1/2 tablet oncea day1 tablet twicea day
    children under2 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, dicalciumphosphate, hypromellose, magnesium stearate, maltodextrin, microcrystallinecellulose, mineral oil, polyethylene glycol, talc

  • SPL UNCLASSIFIED SECTION

    ©2020

    Avrio Health L.P.

    305616-0B

  • PRINCIPAL DISPLAY PANEL

    50 Tablets
    NDC 67618-300-50

    50 Tablets Label
    50 Tablets Leaflet
    50 Tablets Carton

    100 Tablets
    NDC 67618-300-10

    100 Tablets Label
    100 Tablets Leaflet
    100 Tablets Carton
  • 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 DrugM00706/01/1956
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
    Registrant - Atlantis Consumer Healthcare, Inc. (118983925)
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