Label: SENNA-LAX- sennosides tablet, film coated
SENNOSIDES tablet, film coated

  • NDC Code(s): 0904-6522-61, 0904-6725-59, 0904-6725-80
  • 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 December 10, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally causes a bowel movement in 6-12 hours
  • WARNINGS

    Do not use

    • laxative products for longer than one week unless directed by a doctor

    Do not use

    laxative products for longer than one 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 care 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 older

    2 tablets

    once a day

    4 tablets

    twice a day

    Children 6 to under

    12 years of age

    1 tablet

    once a day

    2 tablets

    twice a day

    Children 2 to under

    6 years of age

    1/2 tablet

    once a day

    1 tablet

    twice a day

    Children under

    2 years of age

    ask a doctor

    ask a doctor

  • Other information

    • Each tablet contains: Calcium 25 mg
    • Store at room temperature
  • Inactive ingredients

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

  • Questions or comments?

    (800) 616-2471

  • SPL UNCLASSIFIED SECTION

    Tamper Evident:

    Do not use if sealed blister units are broken or damaged.

    Product color may slightly vary

    due to natural changes of ingredients.

    Distributed by:

    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152

  • PRINCIPAL DISPLAY PANEL

    NDC 0904-6725-80

    MAJOR®

    Senna Tablets

    Natural Vegetable Laxative Ingredient

    For Gentle, Predictable Relief of Constipation

    Compare to the active ingredient in Senokot® Tablets*

    Sennosides 8.6 mg EACH

    1000 TABLETS

    Major Label

    1122-100BC

  • INGREDIENTS AND APPEARANCE
    SENNA-LAX 
    sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6522
    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)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 1122;1122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6522-6110 in 1 BOX03/07/2016
    110 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 finalpart33403/07/2016
    SENNOSIDES 
    sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6725
    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)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 1122;1122
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6725-801000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2018
    2NDC:0904-6725-591 in 1 CARTON12/20/2018
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/20/2018
    Labeler - Major Pharmaceuticals (191427277)