Label: NATURAL LAXATIVE- sennosides tablet, film coated

  • 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 March 23, 2021

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

  • Active ingredient (in each tablet)

    Sennosides USP, 8.6 mg

  • Purpose

    Laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 6 to 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 and over2 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 (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from moisture
    • use by expiration date on package
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide

  • Questions or comments?

    1-888-287-1915

  • Principal Display Panel

    NDC 49035-892-12

    equate

    Compare to Senokot® active ingredient*

    Natural
    Laxative
    Sennosides USP, 8.6 mg
    Laxative

    • Gentle, overnight relief

    8.6
    mg
    EACH

    100
    TABLETS
     

    Actual Size

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

    DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 

    PRODUCT OF INDIA

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

    50844                    REV1216C29812

    44-298

    44-298

  • INGREDIENTS AND APPEARANCE
    NATURAL LAXATIVE 
    sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-892
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorbrown (greenish brown) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;298
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-892-12100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/199502/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/27/199502/26/2023
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(49035-892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(49035-892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(49035-892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(49035-892)