Label: SENNA LAXATIVE- sennosides tablet

  • 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 November 7, 2022

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  • Active ingredients (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces 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 (1-800-222-1222) right away.

  • Directions

    • take preferably at bedtime or as directed by a doctor
     agestarting dosage maximum dosage 
    adults and children 12 years of age and over2 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 day 1 tablet twice a day 
    children under 2 yearsask a doctor ask a doctor 

  • Other information

    • each tablet contains: calcium 30 mg
    • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
  • Inactive ingredients

    dibasic calcium phosphate dihydrate, croscarmellose sodium, hypromellose, magnesium stearate,  microcrystalline cellulose, silicon dioxide, talc,  triacetin

  • Questions or comments?

    Call toll free 1-855-423-2630

  • Principal Display Panel

    compare to Senokot® active ingredient†

    regular strength

    senna laxative

    sennosides 8.6 mg each

    natural vegetable laxative ingredient

    tablets

    †This product is not manufactured ir distributed by Avrio Health L.P., distributor of Senokot®.

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY UNFI

    PROVIDENCE, RI 02908 USA

  • Product Labeling

    Sennosides 8.6 mg

    EQUALINE Senna Laxative

  • INGREDIENTS AND APPEARANCE
    SENNA LAXATIVE 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-782
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code PS23
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-782-101 in 1 BOX10/29/2021
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33410/29/2021
    Labeler - EQUALINE (SuperValu) (006961411)
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