Label: SENNOSIDES tablet, film coated

  • NDC Code(s): 0904-7252-60, 0904-7252-61, 0904-7252-80
  • Packager: Major Pharmaceuticals
  • 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 May 17, 2022

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  • Drug Facts

    Active ingredient (in each tablet)
    Sennosides 8.6 mg

  • PURPOSE

    Purpose
    Laxative

  • Uses

     relieves occasional constipation (irregularity)
     generally produces a bowel movement in 6-12 hours

  • WARNINGS

     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 (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 day     		4 tablets twice
    a day
    children 6 to under
    12 years     		1 tablet once
    a day     		2 tablets twice
    a day
    children 2 to under
    6 years     		1/2 tablet once
    a day     		1 tablet twice
    a day
    children under
    2 years     		ask a doctorask a doctor

  • Other information

    each tablet contains: calcium 20 mg.
     store in a dry place at 15° – 30°C (59° – 86°F).

  • INACTIVE INGREDIENT

    croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, talc.

  • Questions or comments?

    1-800-616-2471

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    Distributed by:
    MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268


    *This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark Senokot®.

  • PRINCIPAL DISPLAY PANEL

    Major

    NDC 0904-7252-80

    Compare to the active ingredient in Senokot® Tablets*

    Senna Tablets

    Sennosides

    8.6 mg

    Natural Vegetable Laxative Ingredient

    1000 Tablets

    Major Label

  • INGREDIENTS AND APPEARANCE
    SENNOSIDES 
    sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7252
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code W2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7252-60100 in 1 BOTTLE; Type 0: Not a Combination Product05/17/2022
    2NDC:0904-7252-801000 in 1 BOTTLE; Type 0: Not a Combination Product05/17/2022
    3NDC:0904-7252-6110 in 1 BOX, UNIT-DOSE05/17/2022
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/17/2022
    Labeler - Major Pharmaceuticals (191427277)
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