Label: SENNOSIDES AND DOCUSATE SODIUM- sennosides, docusate sodium tablet

  • NDC Code(s): 69618-065-01
  • Packager: Reliable-1 Laboratories 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 August 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drugs Facts

  • Active ingredient (in each tablet)

    Docusate sodium 50 mg

    Sennosides 8.6 mg

  • Purpose

    Stool softener

    Stimulant laxative

  • Uses

    relieves occasional constipation (irregularity)

    generally produces a bowel movement in 6 to 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

  • Warnings

    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

  • Warnings

    Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of a laxative. These may indicate a serious condition.

  • Warnings

    If pregnant or breast-feeding, ask a health professional before use.

  • Warnings

    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

    do not exceed maximum dosage

    agestarting dosagemaximun dosage
    adults and children 12 years of age or older2 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 4 mg, sodium 8 mg

    store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C Yello #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, titanium dioxide

  • Questions or comments?

    Call 516-341-0666

    8:30am-4:30pm ET, Mon-Fri

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-065-01

    Senna Plus

    Sennosides 8.6 mg

    Docusate sodium 50 mg

    NATURAL VEGETABLE

    LAXATIVE AND

    STOOL SOFTENER

    100 TABLETS

    *Compare to active ingredients in SENOKOT-S®

    Rev 01 Reliable-1 Senna Plus 100 ct

  • INGREDIENTS AND APPEARANCE
    SENNOSIDES AND DOCUSATE SODIUM 
    sennosides, docusate sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-065
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code S6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-065-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/01/2020
    Labeler - Reliable-1 Laboratories LLC (079718111)
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