Label: SENNOSIDES tablet

  • NDC Code(s): 10135-314-01
  • Packager: Marlex Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

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  • SPL UNCLASSIFIED SECTION

    SENNOSIDES 8.6mg Tablet

    MarlexPharmaceuticals, Inc.

    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.

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    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 older2 tablets once a day4 tablets twice a day
    children 6 to under 12 years of age1 tablet once a day2 tablets twice a day
    children 2 to under 6 years of age1/2 tablet once a day1 tablet twice a day
    children under 2 yearsask a doctorask a doctor
  • Other information

    • Each tablet contains: Calcium 4mg, Sodium 3mg
    • Store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15° to 30°C (59°-86°F).
  • Inactive ingredients

    Colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid

    *Compare to Senokot®

    Product color may vary slightly due to nature of ingredients.

    *Marlex Pharmaceuticals, Inc. is not affiliated with the owner of the registered trademark Senokot®.

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0314-01

    Sennosides

    8.6 mg

    100 TABLETS

    sennosides-01

  • INGREDIENTS AND APPEARANCE
    SENNOSIDES 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-314
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorbrown (light brown to gray) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code S5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-314-011 in 1 CARTON10/01/2018
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00710/01/2018
    Labeler - Marlex Pharmaceuticals Inc (782540215)
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