Label: SENNA LAXATIVE- sennosides tablet

  • NDC Code(s): 36800-786-01
  • Packager: TOP CARE (Topco Associates LLC)
  • 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 28, 2022

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  • 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 using 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 dosage maximum 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 doctor ask a doctor 

  • Other information

    • each tablet contains: calcium 25 mg
    • store at 25oC (77o F); excursions permitted between 15_30oC (59_86oF)
  • Inactive Ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, liquid paraffin*, magnesium stearate, maltodextrin*, microcrystalline cellulose, mineral oil*, polyethylene glycol*, polyvinyl alcohol*, silicon dioxide*, sodium lauryl sulfate*, stearic acid*, talc*

    *contains one or more of these ingredients

  • Questions or comments?

    Call toll free 1-888-423-0139

  • Principal Display Panel

    COMPARE TO SENOKOT® ACTIVE INGREDIENT†

    Vegetable Laxative 

    SENNOSIDES 8.6 mg • LAXATIVE

    Gentle, Overnight Relief of Constipation

    TABLETS

    GLUTEN FREE

    †This product is not manufactured or distributed by Purdue Products 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 TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    topcare@topco.com  www.topcarebrand.com

  • Product Label

    Sennosides 8.6 mg

    TOPCARE HEALTH Vegetable Laxative

  • INGREDIENTS AND APPEARANCE
    SENNA LAXATIVE 
    sennosides tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-786
    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)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorbrownScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 0813;AV;TCL080;S8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-786-011 in 1 BOX01/31/2016
    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 finalpart33401/31/2016
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
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