Label: NATURAL VEGETABLE LAXATIVE- sennosides tablet, film coated

  • NDC Code(s): 64092-115-24
  • Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
  • 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 30, 2021

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  • 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

    age

    		starting
    dosage    		maximum
    dosage
    adults and
    children 12 years  
    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 (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from moisture
    • see end flap for expiration date and lot number
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-800-426-9391

  • Principal Display Panel

    HEALTHCARE™

    NDC 64092-115-24

    *Compare to the
    active ingredient
    in Senokot®

    NATURAL
    Vegetable Laxative
    TABLETS

    Sennosides USP, 8.6 mg per tablet
    Laxative

    Gentle Relief of Constipation

    30 TABLETS

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

    *This product is not manufactured or distributed by
    Purdue Products L.P., owner of the registered
    trademark Senokot®.     50844     REV1216E29801

    Distributed By:
    Great Lakes Wholesale & Marketing L.L.C.
    3729 Patterson Ave., S.E., Grand Rapids, MI 49512
    www.glwholesale.com

    HEALTHCARE GUARANTEE
    If you are not completely satisfied with this
    product, regardless of reason, return your unused
    portion to Great Lakes Wholesale for a full refund

    Healthcare 44-298

    Healthcare 44-298

  • INGREDIENTS AND APPEARANCE
    NATURAL VEGETABLE LAXATIVE 
    sennosides tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-115
    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)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorbrown (light) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;298
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-115-241 in 1 CARTON01/27/199511/23/2022
    130 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 finalpart33401/27/199511/23/2022
    Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(64092-115)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(64092-115)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(64092-115)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(64092-115)
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