Label: SENNA S- sennosides and docusate sodium tablet, coated

  • NDC Code(s): 53329-989-62
  • 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 December 15, 2022

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  • Active ingredient (in each tablet)

    • Docusate sodium 50 mg
    • Sennosides 8.6 mg
  • Purpose

    Stool softener laxative

    Stimulant laxative

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 6 -12 hours
  • Warnings

    Do not use

    • this product if you are presently taking mineral oil, unless directed by a doctor
    • laxative products for longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • a sudden change in bowel movements that persists over 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 could be signs of 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

    age

    starting

    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 20 mg, sodium 6 mg (VERY LOW SODIUM)
    • store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow#10 aluminum lake, FD&C yellow#6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

  • Questions or comments?

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

  • Manufacturing Information

    Manufactured for:
    Medline Industries, LP
    Three Lakes Drive, Northfield, IL 60093 USA
    Made in USA with domestic and foreign materials
    www.medline.com
    1-800-MEDLINE (633-5463)
    REF: OTCM00011
    V1 RE22HND

  • Package Label

    Label V1 RE22HND

  • INGREDIENTS AND APPEARANCE
    SENNA S 
    sennosides and docusate sodium tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-989
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColororangeScorescore with uneven pieces
    ShapeROUNDSize10mm
    FlavorImprint Code TCL;081
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-989-6260 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/22/2018
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/22/2018
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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