Label: SENNA NATURAL VEGETABLE- sennosides tablet, coated

  • NDC Code(s): 53329-986-30
  • Packager: Medline Industries, LP
  • 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 August 31, 2022

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  • Active ingredient (in each tablet)

    Sennosides 8.6 mg

  • Purpose

    Stimulant laxative

  • Uses

    • relieves occational constipation (irregularity)
    • generally causes 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 movements 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
    • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable
    agestarting dosagemaximum dosage
    adults and children 12 years 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 day1 tablet twice a day
    children under 2 yearsask a doctorask a doctor

  • Other information

    • each tablet contains: calcium 25 mg, sodium 2 mg. (VERY LOW SODIUM)
    • store at 25°C (77°F), excursions permitted between 15°-30°C (59°-86°F)
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

  • Questions or comments?

    Call toll free 1-800-MEDLINE (633-5463)
    Monday-Friday 9AM-5PM CST

  • Manufacturing Information

    Manufactured by:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in the USA with U.S. and Foreign Components

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: OTCM00007

    V2 RH22HND

  • Package Label

    Label V2 RH22HND

  • INGREDIENTS AND APPEARANCE
    SENNA NATURAL VEGETABLE 
    sennosides tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-986
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN) SENNOSIDES A AND B8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Product Characteristics
    ColorbrownScorescore with uneven pieces
    ShapeROUNDSize9mm
    FlavorImprint Code TCL080
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-986-30100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2019
    Labeler - Medline Industries, LP (025460908)
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